Status:
NOT_YET_RECRUITING
Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.
Detailed Description
This study aims to evaluate whether tailored, targeted therapy or immunotherapy can effectively prevent cancer recurrence in patients with early-stage (stage IA-IB) non-small cell lung cancer (NSCLC) ...
Eligibility Criteria
Inclusion
- Age 18-75 years and able to provide written informed consent.
- Primary non-squamous NSCLC confirmed by pathology, with no brain metastases.
- Complete R0 surgical resection (lobectomy, segmentectomy, or pneumonectomy) of stage IA or IB NSCLC (AJCC 8th edition).
- High-risk disease (one or more): low differentiation, solid/micropapillary/complex glandular patterns, vascular invasion, visceral pleural invasion, alveolar space spread, or intermediate/high risk on 14-gene test.
- Documented driver gene status (EGFR mutation, ALK/ROS1 fusion, or wild-type) via postoperative tumor sample.
- ECOG performance status 0 or 1, with stable condition over the last two weeks.
- Surgery within 4-10 weeks before starting treatment, with full recovery.
- Adequate organ function as per protocol-defined labs.
- Negative pregnancy test (if applicable) and use of effective contraception during and 3 months after treatment.
Exclusion
- Evidence of unresectable/metastatic NSCLC, incomplete resection (R1/R2), or wedge resection only.
- Prior systemic therapy (e.g., chemotherapy, targeted therapy, immunotherapy) for the current NSCLC.
- Major surgery (excluding lung cancer surgery) within 3 weeks before first study dose.
- Planned concurrent anti-cancer therapy (chemo, radiotherapy, or targeted therapy) during the study.
- Clinically significant cardiac disorders (e.g., poorly controlled hypertension, recent MI or stroke, prolonged QTc).
- History or suspicion of interstitial lung disease requiring treatment.
- Active or uncontrolled infection (e.g., hepatitis B with detectable HBV DNA, hepatitis C, HIV, active TB).
- Severe GI conditions impairing drug absorption (e.g., Crohn's, ulcerative colitis).
- Use of strong CYP3A inducers/inhibitors within 1 week or ongoing need for warfarin.
- Participation in another interventional trial within 4 weeks or receipt of a live vaccine within 180 days.
- Any condition that may compromise adherence or safety, per investigator judgment.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT06955325
Start Date
May 1 2025
End Date
December 1 2035
Last Update
May 6 2025
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