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Concomitant Radiotherapy, Tremelimumab & Durvalumab for Advanced NSCLC Patients Progressing on First-line Immunotherapy

NCT05000710 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-12-05

No results posted yet for this study

Summary

This is an open-label, single-arm, phase 2a trial with a safety run-in cohort followed by a Simon two-step design expansion cohort, of two checkpoint blockage treatments and radiotherapy in the treatment of locally advanced or metastatic NSCLC who have failed first-line immunotherapy (alone or as a combination regimen with chemotherapy).

Study objectives:

Objective of the safety run-in phase:

• To evaluate safety of the triple combination of irradiation -Durvalumab - Tremelimumab

Co-Primary objectives of the entire study:

* To evaluate safety of the triple combination (as for the run-in phase).
* To evaluate response rate on study drug compared to historical data of response to first-line platinum-doublet chemotherapy and 2nd-line docetaxel.

Secondary objective:

• To evaluate PFS and OS compared to historical data .

Exploratory objectives:

* Examine the mechanism of resistance to first-line immunotherapy .
* Examine the immune response in irradiation -Durvalumab - Tremelimumab treated patients and identify potential predictors of clinical benefit.

Conditions

  • Metastatic or Locally Advanced NSCLC

Interventions

DRUG

Durvalumab

Durvalumab administered IV over 60 minutes at a dose of 1500 mg every 4 weeks

DRUG

Tremelimumab

Tremelimumab administered IV over 60 minutes at a dose of 300 mg , twice: at C1D1 and C4D1

RADIATION

Low dose irradiation

21 days after the first immunotherapy treatment 11 fractions of 3 Gy will be administrated to metastatic or primary lesion/s over 2 weeks and one day

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Rambam Health Care Campus

    collaborator OTHER

  • Tel-Aviv Sourasky Medical Center

    collaborator OTHER_GOV

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Jair Bar, Dr · Shaba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Israel

Study Locations

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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 NCT05000710 on ClinicalTrials.gov