Clinical trial · Interventional
Induction Chemo-Nivo in Unresectable Stage III NSCLC
Phase II Study of Induction Platinum Doublet in Combination With Nivolumab Followed by Surgery or Concurrent Chemoradiation in Unresectable Stage IIIA-C Non-small Cell Lung Cancer (NSCLC)
NCT06003075CI-TRIAL-00089133terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Cancer Stage III | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Nivolumab and Chemotherapy | Combination Product | — | UNRESOLVED |
| Post Induction Surgery | Procedure | — | UNRESOLVED |
| Post Induction XRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combination Chemotherapy and Nivolumab and Surgery
- description
- Patients with lung cancer receiving combination therapy with surgery
- interventionNames
- Combination Product: Nivolumab and Chemotherapy
- Drug: Nivolumab
- Procedure: Post Induction Surgery
- Radiation: Post Induction XRT
- type
- EXPERIMENTAL
- label
- Combination Chemotherapy and Nivolumab and Radiation
- description
- Patients with lung cancer receiving combination therapy with radiation
- interventionNames
- Combination Product: Nivolumab and Chemotherapy
- Drug: Nivolumab
- Radiation: Post Induction XRT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated * PD-L1 level needs to be measured with values 0-100% eligible * EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes * ECOG Performance Status ≤ 1 * Adequate organ and marrow function * Adequate pulmonary reserve (e.g., FVC, FEV1, TLC, FRC, and DLCO) capable of tolerating the proposed lung resection * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen * Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification class 2B or better * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment * Any prior radiotherapy to the lung * Any prior treatment for NSCLC * Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways * Any history of a severe hypersensitivity reaction to any monoclonal antibody * Any history of allergy to the study drug components * primary tumors involving the esophagus * pancoast tumors * Patients cannot have primary tumors which would remain unresectable * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in study * Any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications * Ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg * previous malignancies * history of interstitial lung disease * Patients requiring continuous supplemental oxygen * Use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy * Active systemic infection requiring therapy * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.