A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer (D4190C00006)

MedImmune

Status and phase: Completed; Phase 1

Conditions: Non-small Cell Lung Cancer; Lung Cancer; NSCLC

Treatments: Drug: MEDI4736; Drug: tremelimumab; Drug: Tremelimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02000947

D4190C00006

2015-003715-38 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).

Full description

This is a multicenter, open-label, dose-escalation, and dose expansion study of MEDI4736 in combination with tremelimumab to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and antitumor activity of MEDI4736 in combination with tremelimumab in adult subjects with advanced NSCLC.

Enrollment: 459 patients

Sex: All

Ages: 18 to 101 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Advanced non-small cell lung cancer
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
4. Adequate organ and marrow function

Exclusion criteria

1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
3. Active or prior documented autoimmune disease within the last 2 years.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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459 participants in 4 patient groups

Dose Escalation

Experimental group

Description:

MEDI4736 and tremelimumab received by intravenous infusion.

Treatment:

Drug: MEDI4736

Drug: Tremelimumab

Arm A

Experimental group

Description:

Medi4736 and tremelimumab received by intravenous infusion

Treatment:

Drug: MEDI4736

Drug: Tremelimumab

Arm B

Experimental group

Description:

MEDI4736 and tremelimumab received by intravenous infusion

Treatment:

Drug: MEDI4736

Drug: tremelimumab

Arm C

Experimental group

Description:

MEDI4736 and tremelimumab received by intravenous infursion

Treatment:

Drug: MEDI4736

Drug: tremelimumab