MedTrace Logo

Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC

NCT04163432 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-05-19

Study results available
· View outcomes & findings →

Summary

This is a Phase II, open label, randomized study of durvalumab in combination with pemetrexed and carboplatin in eligible adult patients with locally advanced or metastatic non-small cell lung cancer. The study will focus on the efficacy of two alternative staggered dosing regimens.

Conditions

  • Non-Small Cell Lung Cancer Metastatic

Interventions

DRUG

Carboplatin

Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.

DRUG

Durvalumab

Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized

DRUG

Pemetrexed

Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2.

Sponsors & Collaborators

Principal Investigators

  • Matthew Gumbleton, MD · Huntsman Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2025-02-04
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163432 on ClinicalTrials.gov