At a glance
ClinicalIndex Comparison Record- ✓Untreated stage II-III NSCLC with operable and resectable disease
- ✓Histologic confirmation of disease
- ✓Age 18 years or older
- ✓Karnofsky Performance Status ≥70
- ✕Presence of FDA approved targeted therapy for patients with genomic aberrations for which targeted therapy is indicated
- ✕Hypersensitivity to platinum agents
- ✕Prior use of TNF-α inhibitor
- ✕Systemic immunosuppressive medication within 2 weeks prior to treatment initiation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Trial of Neoadjuvant Nivolumab + Platinum-based Chemotherapy + Certolizumab in Patients With Resectable Stages II-III Lung Cancers
In Brief
A Phase 2 clinical trial evaluating Cisplatin, Pemetrexed, and 4 other interventions for Lung Cancer and 2 related conditions. Currently recruiting, targeting 60 participants across 7 sites.
Signals
Detailed Summary
The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.
Study Details
Timeline
Interventions
Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle. Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.
Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle
Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.
Participants not eligible for cisplatin (per treating physician discretion) may receive carboplatin at AUC = 5 instead of cisplatin.
Certolizumab 400mg subq will be administered in clinic within 1 hour before the start of chemotherapy on day 1 of a 21 day cycle.
Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 + nivolumab 360mg intravenously on day 1 of a 21 day cycle Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of 21 day cycle + nivolumab 360mg IV on day 1 of 21 day cycle.