Clinical trial · Interventional
An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease
A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed
Summary
Brief summary (as posted)
The purpose of this study is to determine if nivolumab added to the standard of care therapy (SOC) given after surgery is more effective than SOC alone in prolonging disease free survival in NSCLC participants with minimal residual disease detected after surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor DNA | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Observation | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Vinorelbine | Drug |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Nivolumab + SOC (chemotherapy in eligible participants or observation)
- interventionNames
- Biological: Nivolumab
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Docetaxel
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Paclitaxel
- Other: Observation
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- SOC (chemotherapy in eligible participants or observation)
- interventionNames
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Docetaxel
- Drug: Pemetrexed
- Drug: Cisplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria prior to Surgery: * Suspected or histologically confirmed Stage IIA to IIIB NSCLC with disease that is considered resectable * Must be deemed eligible for complete resection and must agree to undergo standard of care surgery for complete resection of NSCLC * Treatment naive (no previous systemic treatment) Inclusion Criteria prior to Treatment Randomization: * Must have undergone complete surgical resection of their Stage IIA to IIIB NSCLC * Must have adequately recovered from surgery at the time of randomization * Minimal residual disease (MRD) positive results as detected by ctDNA Exclusion Criteria prior to Surgery: * Participants with known EGFR mutations which are sensitive to available targeted inhibitor therapy (Prior to treatment randomization in select sites) * Active, known or suspected autoimmune disease * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization Exclusion Criteria prior to Treatment Randomization: * Must continue to meet Exclusion Criteria prior to Surgery * Must have no evidence of metastatic disease after surgery * Received a live/attenuated vaccine within 30 days of first treatment Other protocol defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available