Trials / Withdrawn
WithdrawnNCT03770299
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| DRUG | Vinorelbine | Specified dose on specified days |
| DRUG | Gemcitabine | Specified dose on specified days |
| DRUG | Docetaxel | Specified dose on specified days |
| DRUG | Pemetrexed | Specified dose on specified days |
| DRUG | Cisplatin | Specified dose on specified days |
| DRUG | Carboplatin | Specified dose on specified days |
| DRUG | Paclitaxel | Specified dose on specified days |
| OTHER | Observation | Observation by the investigator |
Timeline
- Start date
- 2021-01-15
- Primary completion
- 2023-03-14
- Completion
- 2024-03-14
- First posted
- 2018-12-10
- Last updated
- 2022-03-24
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03770299. Inclusion in this directory is not an endorsement.