## Protocol Section
### Identification Module
**NCT ID:** NCT06431633

**Acronym:** ARIAN

**Brief Title:** Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.

**Official Title:** A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN

#### Organization Study ID Info
**ID:** GECP 23/03_ARIAN
#### Organization
**Class:** OTHER
**Full Name:** Fundación GECP
### Status Module
#### Completion Date
**Date:** 2031-06-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2031-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-16

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundación GECP

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.

129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment.

This clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles.

The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.

**Detailed Description:** This is an open-label, phase II, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.

Patients stage IB to IIIA-IIIB (T3N2) after surgical resection if they did not achieve a pathological com-plete response (pCR) will be randomized 1:1:1 to:

* ARM 1: Observational Arm for 10 months
* ARM 2: Immunotherapy (Zimberelimab) treatment for 13 cycles, Q3W
* ARM 3: Sacituzumab Govitecan + Zimberelimab Q3W for 8 cycles + Zimberelimab Q3W for 5 cycles. Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy.

The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Disease Free survival (DFS): The time from random assignment to cancer recurrence or death from any cause.

Secondary objectives:

* Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment
* Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0.

Exploratory objectives

- To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS.

The total trial duration will be 7 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. One year of treatment and 3 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded

### Conditions Module

**Conditions:**

- Lung Diseases

- Carcinoma, Non-Small-Cell Lung

- Resectable Lung Non-Small Cell Carcinoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 129

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients randomized in this arm will be in observation for 10 months. It is allowed to administer adjuvant treatment according to investigator criteria. Immunotherapy is not allowed in this arm, only chemotherapy treatment is allowed.

**Intervention Names:**

- Drug: Cisplatin

- Drug: Carboplatin

**Label:** ARM 1: Observation-investigator decision

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Adjuvant treatment with Zimberelimab will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W).

Zimberelimab: day 1 360 mg IV Q3W (13 cycles)

**Intervention Names:**

- Drug: Zimberelimab

**Label:** ARM 2: Immunotherapy. Zimberelimab treatment for 13 cycles

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Sacituzumab Govitecan: day 1 and 8; 10mg/Kg IV Q3W Zimberelimab: day 1 360 mg IV Q3W

Treatment sequence:

Adjuvant treatment will start between the 3rd to the 10th week from surgery. 13 cycles will be administered in total. Cycles will be administered in 21-day intervals (Q3W).

Patients will receive 8 cycles of Sacituzumab Govitecan + Zimberelimab and 5 cycles of Zimberelimab monotherapy.

**Intervention Names:**

- Drug: Zimberelimab

- Drug: Sacituzumab govitecan

**Label:** ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ARM 2: Immunotherapy. Zimberelimab treatment for 13 cycles

- ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles

**Description:** Zimberelimab is a fully human IgG4 monoclonal antibody targeting human PD-1. PD-1 is a type I transmembrane protein that is part of the immunoglobulin gene superfamily and the CD28 family of cell surface receptors. PD-1 is an inhibitory immune checkpoint protein that is expressed on activated B cells, T cells, and myeloid cells, and it plays a key role in limiting the activity of effector T cells.

Zimberelimab is formulated at 30 mg/mL in a buffer solution containing histidine/histidine-HCl buffer solution, sucrose, sodium chloride, and polysorbate 80, at pH 5.5. The investigational product is supplied as a vial contains 120 mg of active Zimberelimab at a concentration of 30mg/mL.

No premedication nor profilaxis is needed before Zimberelimab administration. Zimberelimab doses are administered by IV infusion over 60 minutes, followed by a 30- to 60-minute observation period, on D1 of each 21-day cycle.

**Name:** Zimberelimab

**Other Names:**

- anti-PD-1 monoclonal antibody AB122

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- ARM 3: Sacituzumab Govitecan + Zimberelimab for 8 cycles + Zimberelimab for 5 cycles

**Description:** Sacituzumab govitecan (SG) is an ADC composed of the following 3 components:

o The humanized monoclonal antibody hRS7 IgG1κ, which binds to Trop-2, a transmembrane calcium signal transducer that is overexpressed in many epithelial cancers.

o The camptothecin-derived agent SN-38, a topoisomerase I inhibitor. o A hydrolyzable linker, with the company designation as CL2A that links the humanized monoclonal antibody to SN-38.

Sacituzumab govitecan is approved globally for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and HR+ breast cancer.

**Name:** Sacituzumab govitecan

**Other Names:**

- Trodelvy

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- ARM 1: Observation-investigator decision

**Description:** Cisplatin-based adjuvant chemotherapy

Cisplatin - CAS 15663-27-1, is a platinum coordination complex with potent anti-neoplastic activity. Induces apoptosis in cancer cells, possibly via caspase-3 activation.

**Name:** Cisplatin

**Other Names:**

- Platinol

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- ARM 1: Observation-investigator decision

**Description:** Cisplatin-based adjuvant chemotherapy Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center. Other Name: ATC code: L01XA02

**Name:** Carboplatin

**Other Names:**

- Paraplatin

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Analyze plasma samples and quantifying the amount of circulating tumor DNA (ctDNA) by NGS.

**Measure:** Change in levels of ctDNA during treatment

**Time Frame:** To analyze at pretreatment, after 6 months of treatment, and at disease relapse, assessed up to 36 months

#### Primary Outcomes

**Description:** Defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

**Measure:** Disease free survival

**Time Frame:** The time from random assignment to cancer recurrence or death from any cause, assessed up to 36 months

#### Secondary Outcomes

**Description:** defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.

**Measure:** Overall survival

**Time Frame:** To evaluate at 12, 24 and 36 months after the start of adjuvant treatment

**Description:** Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

**Measure:** Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

**Time Frame:** From the subject's written consent to participate in the study through 180 days after the final administration of the drug

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed.
* 2. Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA or IIIB (N2) according to pathological criteria (pTNM) and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
* 3. Complete surgical resection (R0) of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide. Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station
* 4. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study except if R0 resection can be confirmed.
* 5. Only patients that do not achieve pathological complete response (pCR) seen in the surgical piece after neoadjuvant therapy are eligible.
* 6. Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory.
* 7. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible.
* 8. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery.
* 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* 10. Patients aged ≥ 18 years.
* 11. PDL1 value analysed locally (hospital must be able to provide this value before randomization)
* 12. PET-CT and brain CT before randomization to confirm the absence of distant disease.
* 13. Adequate hematologic and organ function
* 14.All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
* 15.For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
* 16. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
* 17. Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs.
* 18.Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.
* 19.Patient capable of proper therapeutic compliance and accessible for correct follow-up
* 20. Patients with a life expectancy of at least more than 12 weeks

Exclusion Criteria:

* 1. Patients with a history of other malignant diseases, with the exception of the following:

  * properly treated non-melanotic skin cancer
  * cancer in situ treated with curative intent or other malignancies treated with curative intent and without signs of disease for a period of\> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease.
* 2.T4 patients with invasion of heart, great vessels, carina, trachea, oesophagus or spine
* 3. Patients with ALK translocation, STK11 o KEAP1 known mutations before inclusion in this trial.
* 4. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study.
* 5. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma
* 6. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of randomization.
* 7. Patients that received live attenuated vaccines within 30 days prior to randomization
* 8. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments
* 9. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol.
* 10. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction
* 11. Pregnant or breastfeeding women
* 12. Patients in whom R0 resection cannot be confirmed.
* 13. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* 14.Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* 15. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.
* 16. History of allergy or hypersensitivity to any of the study drug components
* 17. Pleural or pericardial effusion, both will be considered indicative of metastatic disease unless proven otherwise. Patients with pleural effusion not visible on chest-X-ray or too small to perform diagnostic puncture safely may be included.
* 18. Have known history of HIV-1 or 2 with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
* 19.Severe infections within 4 weeks prior to be included in the study, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
* 20.Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures.
* 21. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder; any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement; or prior pneumonectomy.
* 22. Treatment with systemic immunosuppressive medications
* 23.Patients with uncontrolled comorbidities that may affect the clinical trial compliance.
* 24.Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gecp@gecp.org

**Name:** Eva Pereira

**Phone:** +34 934302006

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Elche

**Contacts:**

***Contact 1:***

- **Name:** Miguel Borregón Rivilla, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Miguel Borregón Rivilla, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital General de Elche

**State:** Alicante

**Zip:** 03203

**Location 2:**

**City:** Badalona

**Contacts:**

***Contact 1:***

- **Name:** Marta Domenech, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Marta Domenech, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** ICO Badalona, Hospital Germans Trias i Pujol

**State:** Barcelona

**Zip:** 08916

**Location 3:**

**City:** Hospitalet de Llobregat

**Contacts:**

***Contact 1:***

- **Name:** Ernest Nadal, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ernest Nadal, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** ICO Hospitalet

**State:** Barcelona

**Zip:** 08908

**Location 4:**

**City:** Jerez De La Frontera

**Contacts:**

***Contact 1:***

- **Name:** Mª Ángeles Moreno, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mª Ángeles Moreno, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario Jerez De La Frontera

**State:** Cádiz

**Zip:** 11407

**Location 5:**

**City:** A Coruña

**Contacts:**

***Contact 1:***

- **Name:** Rosario García Campelo, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Rosario García Campelo, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospitalario Universitario A Coruña

**State:** La Coruña

**Zip:** 15006

**Location 6:**

**City:** Las Palmas De Gran Canaria

**Contacts:**

***Contact 1:***

- **Name:** David Aguiar Bujanda, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** David Aguiar Bujanda

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitari de Gran Canària Doctor Negrín

**State:** Las Palmas

**Zip:** 35010

**Location 7:**

**City:** Majadahonda

**Contacts:**

***Contact 1:***

- **Name:** Mariano Provencio, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mariano Provencio, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario Puerta de Hierro

**State:** Madrid

**Zip:** 28222

**Location 8:**

**City:** Palma De Mallorca

**Contacts:**

***Contact 1:***

- **Name:** Aitor Azkárate Martínez, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Aitor Azkárate Martínez, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital de Son Espases

**State:** Mallorca

**Zip:** 07120

**Location 9:**

**City:** Vigo

**Contacts:**

***Contact 1:***

- **Name:** Gerardo Huidobro, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Gerardo Huidobro, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Complejo Hospitalario Universitario de Vigo

**State:** Pontevedra

**Zip:** 36036

**Location 10:**

**City:** Reus

**Contacts:**

***Contact 1:***

- **Name:** Clara Lucía Gozálvez, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Clara Lucía Gozálvez, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitari Sant Joan de Reus

**State:** Tarragona

**Zip:** 43204

**Location 11:**

**City:** Alicante

**Contacts:**

***Contact 1:***

- **Name:** Bartomeu Massuti, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Bartomeu Massuti, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital General Universitario de Alicante

**Zip:** 03010

**Location 12:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Name:** Alex Martínez, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Alex Martínez, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitari Vall d' Hebron

**Zip:** 08035

**Location 13:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Name:** Noemí Reguart

- **Role:** CONTACT

***Contact 2:***

- **Name:** Noemí Reguart, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Clínic De Barcelona

**Zip:** 08036

**Location 14:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Name:** Andres Barba, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Andres Barba, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital de la Santa Creu i Sant Pau

**Zip:** 08041

**Location 15:**

**City:** Barcelona

**Contacts:**

***Contact 1:***

- **Name:** Laia Vilà, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Laia Vilà, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Parc Taulí

**Zip:** 08208

**Location 16:**

**City:** Bilbao

**Contacts:**

***Contact 1:***

- **Name:** Mª Ángeles Sala, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mª Ángeles Sala, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital De Basurto

**Zip:** 48013

**Location 17:**

**City:** León

**Contacts:**

***Contact 1:***

- **Name:** Blanca Távara, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Blanca Távara, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario de León

**Zip:** 24071

**Location 18:**

**City:** Lugo

**Contacts:**

***Contact 1:***

- **Name:** Begoña Campos, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Begoña Campos, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario Lucus Augusti

**Zip:** 27003

**Location 19:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Monica Antoñanzas, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Monica Antoñanzas, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Clínico San Carlos

**Zip:** 28040

**Location 20:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Manuel Dómine, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Manuel Dómine, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario Fundación Jiménez Díaz

**Zip:** 28040

**Location 21:**

**City:** Madrid

**Contacts:**

***Contact 1:***

- **Name:** Javier De Castro, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Javier De Castro, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario la Paz

**Zip:** 28046

**Location 22:**

**City:** Ourense

**Contacts:**

***Contact 1:***

- **Name:** Karmele Areses, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Karmele Areses

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Santa María Nai

**Zip:** 32005

**Location 23:**

**City:** Palma De Mallorca

**Contacts:**

***Contact 1:***

- **Name:** Juan Coves Sarto, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Juan Coves Sarto, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitari Son Llatzer

**Zip:** 07198

**Location 24:**

**City:** Salamanca

**Contacts:**

***Contact 1:***

- **Name:** Alejandro Olivares Hernández, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Alejandro Olivares Hernández, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario Salamanca

**Zip:** 37007

**Location 25:**

**City:** Santa Cruz De Tenerife

**Contacts:**

***Contact 1:***

- **Name:** Karla Mercedes Medina, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Karla Mercedes Medina, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario Nuestra Señora La Candelaria

**Zip:** 38009

**Location 26:**

**City:** Sevilla

**Contacts:**

***Contact 1:***

- **Name:** Reyes Bernabé, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Reyes Bernabé, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Virgen del Rocío

**Zip:** 41013

**Location 27:**

**City:** Terrassa

**Contacts:**

***Contact 1:***

- **Name:** Remei Blanco, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Remei Blanco, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Consorci Sanitari de Terrassa

**Zip:** 08227

**Location 28:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Name:** Amelia Insa, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Amelia Insa, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Clínico de Valencia

**Zip:** 46010

**Location 29:**

**City:** Valencia

**Contacts:**

***Contact 1:***

- **Name:** Oscar Juan-Vidal, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Oscar Juan-Vidal, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Universitario La Fe

**Zip:** 46026

**Location 30:**

**City:** Valladolid

**Contacts:**

***Contact 1:***

- **Name:** Rafael López, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Rafael López, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Spain

**Facility:** Hospital Clínico Universitario de Valladolid

**Zip:** 47003

#### Overall Officials

**Official 1:**

**Affiliation:** President of Fundacion GECP

**Name:** Mariano Provencio, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** Web page of the sponsor where users can find more information about Fundación GECP studies

**URL:** http://www.gecp.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Carcinoma, Non-Small-Cell Lung

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Lung Disease

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

- ID: D000008171

- Term: Lung Diseases

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000018796

- Term: Immunoconjugates

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: AA

- Name: Amino Acids

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M1671

- Name: Irinotecan

- Relevance: LOW

- As Found: Unknown

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

- ID: M287620

- Name: Sacituzumab govitecan

- Relevance: HIGH

- As Found: Major Depression

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M6182

- Name: Cisplatin

- Relevance: LOW

- As Found: Unknown

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5426

- Name: Camptothecin

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M29349

- Name: Topoisomerase I Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M20855

- Name: Immunoconjugates

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: T8

- Name: Histidine

- Relevance: LOW

- As Found: Unknown

- ID: T395

- Name: Glucosamine

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016190

- Term: Carboplatin

- ID: C000608132

- Term: Sacituzumab govitecan

### Misc Info Module

- Version Holder: 2024-05-31
