NCT04699123

The Study of NC318 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to investigate NC318 alone or in combination with Pembrolizumab in patients with advanced non-small cell lung cancer.

Detailed description

This is a non-randomized, three-arm trial. Arm 1a and 1b will enroll patients with advanced NSCLC regardless of tumor PD-L1 expression who have experienced disease progression on or after PD-1 axis inhibitor therapy, given alone or in combination with other systemic anti-cancer therapy. Patients will be assigned to arm 1a or 1b at the discretion of the treating physician. Patients on arm 1a will receive NC318 alone; those on arm 1b, combination therapy with NC318 and pembrolizumab. Arm 1a will be based on a Simon two-stage minimax design. In the first stage, 18 patients will be accrued. If tumor response per RECIST v1.1 is achieved in 2 or fewer patients, arm 1a will be closed to further enrollment. If tumor response is demonstrated in 3 or more patients, then 25 additional patients will be accrued (stage 2), for a total of 43 patients. Arm 1a and 1b will start with a safety run-in portion consisting of 6 patients (see 4.1.1). If deemed safe, each arm will continue to accrue and follow the Simon two-stage design outlined above. Patients in the run-in portion will be included in stage 1 of the Simon two-stage design. Arm 2 will enroll patients with advanced NSCLC and tumor PD-L1 expression less than 50% who are naïve to PD-1 axis inhibitor therapy. Patients on arm 2 will receive combination therapy with NC318 and pembrolizumab. Arm 2 will also start with a safety run-in portion identical to that of arms 1a and 1b (see 4.1.1). If deemed safe, accrual will continue following a Simon two-stage minimax design. In the first stage, 19 patients will be accrued. If tumor response per RECIST v1.1 is achieved in 3 or fewer patients, arm 2 will be closed to further enrollment. If tumor response is demonstrated in 4 or more patients, then 36 additional patients will be accrued (stage 2), for a total of 54 patients. Patients in the run-in portion will be included in stage 1 of the Simon two-stage design. The study protocol was amended to add 2 additional arms 5/2023. Arms 1c and 2a will receive NC318 800 mg, IV weekly for 8 doses, followed by every 2 week dosing. They both follow the same procedures as the earlier arms in the study. Arm 2 has essentially been removed from the study- but remains included in the protocol registration. In addition, patients treated on arm 1a will be allowed to receive combination therapy with NC318 and pembrolizumab at the time of progression, after a mandatory tumor biopsy. They will be considered separately from arm 1c.

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	NC318 800 mg	NC318 will be given intravenously (IV) weekly for 8 doses and then every 2 weeks for patients receiving combination therapy treatment or weekly for patient receiving NC318 in monotherapy.
DRUG	NC318 400 mg	NC318 will be given intravenously (IV) every 2 weeks.
DRUG	Pembrolizumab	Pembrolizumab 200 mg will be given IV every 3 weeks

Timeline

• Start date: 2021-02-04
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2021-01-07
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study