Who is sponsoring NCT03377023?

NCT03377023 is sponsored by H. Lee Moffitt Cancer Center and Research Institute.

What condition does NCT03377023 study?

NCT03377023 studies Non Small Cell Lung Cancer, Lung Cancer, Nonsmall Cell, Non Small Cell Lung Cancer Metastatic.

What drugs are being tested in NCT03377023?

Interventions: Nivolumab, Ipilimumab, Nintedanib.

What is the status of NCT03377023?

NCT03377023 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2026-03-31 · How we verify

Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer

NCT03377023 Phase 1/Phase 2 ACTIVE_NOT_RECRUITING Results posted

The main purpose of this study is to see if the combination of nivolumab, ipilimumab and nintedanib is effective in people with non- small cell lung cancer. Researchers also want to find out if the combination of nivolumab, ipilimumab and nintedanib is safe and tolerable.

Details

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 1/Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	66
Start date	2018-02-02
Completion	2026-08

Conditions

Non Small Cell Lung Cancer
Lung Cancer, Nonsmall Cell
Non Small Cell Lung Cancer Metastatic

Interventions

Nivolumab
Ipilimumab
Nintedanib

Primary outcomes

Phase 1 - Maximum Tolerated Dose (MTD) — Up to 12 months
Dose escalation to determine the MTD and Recommended Phase 2 Dose (RP2D) of concurrent administration of nivolumab, ipilimumab, and nintedanib. The maximum tolerated dose (MTD) is defined as the dose with the dose limiting toxicity (DLT) rate of 30%. Phase 1 began with 100 mg nintedanib, 3 mg/kg IV nivolumab + 1 mg/kg ipilimumab. Dosing of nintedanib increased by 50 mg in each level until dose limiting toxicity.
Phase 2 - Objective Response Rate (ORR) Per Treatment Arm — Up to 36 months
Objective response is defined as confirmed CR or confirmed PR based on modified RECIST guidelines version 1.1. The ORR will be estimated by calculating the proportion of patients who achieve OR; the 80% Confidence Interval (CI) and 95% CI for the OR rate will be estimated using the exact binomial distribution. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Countries

United States