NCT06955325Not yet recruitingPhase 3
Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations
A Randomized, Phase III Umbrella Trial of Adjuvant Therapy Versus Observation in Completely Resected High-Risk Stage IA-IB Non-Small Cell Lung Cancer Based on Oncogenic Driver Mutations
Source: ClinicalTrials.gov · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 16 Apr 2025
- Start date
- May 2025
- Primary completion date
- Dec 2030
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT06955325
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 270
- From May 2025 to the primary completion date, Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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).
- Any condition that may compromise adherence or safety, per investigator judgment.
Lab values
- Clinically significant cardiac disorders (e.g., poorly controlled hypertension, recent MI or stroke, prolonged QTc).
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.