Overview

This trial is active, not recruiting.

Condition patients with non-small cell lung cancer(nsclc)
Treatments gefitinib, medi4736
Phase phase 1
Targets PD-1, EGFR
Sponsor MedImmune LLC
Collaborator AstraZeneca
Start date March 2014
End date June 2019
Trial size 56 participants
Trial identifier NCT02088112, D791PC00001

Summary

This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
MEDI4736 will be combined with gefitinib to assess safety and tolerability
gefitinib
Gefitinib QD
medi4736
MEDI4736 IV Q2W
(Experimental)
MEDI4736 will be combined with gefitinib
gefitinib
Gefitinib QD
medi4736
MEDI4736 IV Q2W

Primary Outcomes

Measure
Escalation Phase: safety and tolerability: AEs, laboratory data, vital signs, ECG changes and Echo. Expansion Phase: safety and tolerability of the recommended dose for MEDI4736; AEs, laboratory data, vital signs, ECG changes and Echo.
time frame: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months

Secondary Outcomes

Measure
To obtain a preliminary assessment of the anti-tumour activity of gefitinib in combination with MEDI4736 by evaluation of tumour response
time frame: From baseline assessment to disease progression, assessed up to 30 months
To determine the immunogenicity of MEDI4736 in combination with gefitinib: anti-drug antibodies (ADAs)
time frame: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To determine the pharmacokinetics of MEDI4736
time frame: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To assess MEDI4736 pharmacodynamics in subjects receiving MEDI4736 in combination with gefitinib.
time frame: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To determine overall survival (OS) in expansion Arm 1 and Arm 1a patients
time frame: From final safety follow-up visit after last dose until 36 months after Last Subject enrolled

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

Key Inclusion Criteria: 1. Provision of signed and dated, written informed consent 2. Male or female aged 18 years and older. 3. Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. In the expansion phase, histologically or cytologically confirmed locally advanced or metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and sensitive to EGFR TKIs therapy 4. a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - For Japan Escalation - the same as the global escalation I/E criteria except patients must be EGFR mutation positive Key Exclusion Criteria: 1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. 2. Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment 3. Inadequate bone marrow reserve or organ function

Additional Information

Official title A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Gefitinib in Combination With MEDI4736 (Anti PD-L1) in Subjects With Non-Small Cell Lung Cancer(NSCLC)
Principal investigator Ben Creelan, MD
Description In Escalation phase: MEDI4736 and gefitinib in NSCLC subjects In Expansion phase: Subjects with EGFR mutation positive locally advanced or metastatic NSCLC will be enrolled in expansion arms. Initiation of expansion arms with the recommended dose of MEDI4736 in combination with gefitinib will be based on an adequate safety and tolerability profile of the combination from the escalation phase.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by MedImmune LLC.