## Protocol Section
### Identification Module
**NCT ID:** NCT06422546

**Acronym:** pre-FLAME

**Brief Title:** A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC

**Official Title:** A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC

#### Organization Study ID Info
**ID:** pre-FLAME
#### Organization
**Class:** OTHER
**Full Name:** Beijing Cancer Prevention & Treatment Society
### Status Module
#### Completion Date
**Date:** 2025-06-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-01-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Cancer Prevention & Treatment Society

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC

**Detailed Description:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment.To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment.

### Conditions Module

**Conditions:**

- Non Small Cell Lung Cancer

### Design Module

#### Bio Spec

**Description:** EGFR mutation in plasma

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 950

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Other Outcomes

**Description:** To evaluate the mechanism of oxitinib treatment resistance and describe the characteristics of genetic variation associated with oxitinib treatment at baseline and 3 weeks after treatment

**Measure:** describe the characteristics of genetic variation associated with oxitinib treatment

**Time Frame:** baseline and 3 weeks after oxitinib treatment

#### Primary Outcomes

**Description:** To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment

**Measure:** changes in EGFR gene mutations

**Time Frame:** baseline and 3 weeks after oxitinib treatment

#### Secondary Outcomes

**Description:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment

**Measure:** Characteristics of EGFR gene mutation and efficacy of oxitinib treatment

**Time Frame:** baseline and 3 weeks after oxitinib treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. ≥18 years old male or female
2. Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8);
3. Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy;
4. EGFR positive in blood or tissue tested in local laboratory;
5. Sufficient blood samples can be provided for molecular detection;
6. Signed informed consent forms are available.

Exclusion Criteria:

1. Patients were unable to collect plasma samples at baseline;
2. The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory;
3. The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** stage IV metastatic or recurrent non-squamous EGFR-positive NSCLC

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** qld@bcpts.org.cn

- **Name:** Qu Liudi

- **Phone:** 18519773872

- **Role:** CONTACT

***Contact 2:***

- **Email:** xueying.du@halmaorient.com

- **Name:** Du Xueying

- **Phone:** 18811792675

- **Role:** CONTACT

**Country:** China

**Facility:** Beijing Cancer Prevention society

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100021

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- 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

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Non-Small Cell Lung Cancer

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- 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

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Misc Info Module

- Version Holder: 2024-05-31
