Clinical trial · Interventional

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

NCT06955325CI-TRIAL-00089364UPLIFTnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-Small Cell Lung Cancer	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Benmelstobart	Drug	—	UNRESOLVED
Ensartinib	Drug	Ensartinib	ALIAS
Icotinib	Drug	Icotinib	ALIAS
Rezivertinib	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Adjuvant therapy
interventionNames
1. Drug: Icotinib
2. Drug: Rezivertinib
3. Drug: Ensartinib
4. Drug: Benmelstobart
type
NO_INTERVENTION
label
Observation

Primary outcomes (1)

measure
Disease-Free Survival (DFS)
timeFrame
From randomization until disease recurrence or death (up to approximately 5 years)
description
Disease-free survival (DFS) is defined as the time from randomization to the first documented disease recurrence (local relapse or distant metastasis confirmed by imaging or pathology) or death from any cause, whichever occurs first. Participants without documented recurrence or death at the time of analysis will be censored at their last disease assessment date.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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 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.

References

Publications (0)

Data not yet available

No reference posted for this study.