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RecruitingNCT06422546pre-FLAMEUpdated May 21, 2024

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

An observational study in Non Small Cell Lung Cancer, sponsored by Beijing Cancer Prevention & Treatment Society. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-21.

Sponsored by Beijing Cancer Prevention & Treatment Society · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
950
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 950 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Beijing Cancer Prevention & Treatment Society is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

stage IV metastatic or recurrent non-squamous EGFR-positive NSCLC

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
950 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. changes in EGFR gene mutations

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

    Time frame: baseline and 3 weeks after oxitinib treatment

Secondary outcomes

  1. Characteristics of EGFR gene mutation and efficacy of oxitinib treatment

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

    Time frame: baseline and 3 weeks after oxitinib treatment

Other outcomes

  1. describe the characteristics of genetic variation associated with oxitinib 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

    Time frame: baseline and 3 weeks after oxitinib treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06422546
Lead sponsor
Beijing Cancer Prevention & Treatment Society
Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
Sponsor
First posted
May 21, 2024
Start date
Jan 15, 2022
Primary completion
Jul 31, 2024 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
May 21, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Beijing Cancer Prevention & Treatment Society

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