Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on D… (NCT06955325) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations
270 participantsStarted 2025-05
Plain-language summary
This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 i…
What they're measuring
1
Disease-Free Survival (DFS)
Timeframe: From randomization until disease recurrence or death (up to approximately 5 years)
Trial details
NCT IDNCT06955325
SponsorThe First Affiliated Hospital of Guangzhou Medical University