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A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy

NCT04856176 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-01-01

No results posted yet for this study

Summary

Metastatic lung cancer is the leading cause of cancer mortality worldwide with a 5-year survival of less than 5%. With the approval of programmed cell death 1 (PD-1) inhibitors in advanced lung cancer, such as pembrolizumab, there has been an improvement in overall response rates (ORR) and survival compared to chemotherapy.

However, there is still a need for improvement in response rates in first-line treatments for patients with stage 4 NSCLC without genetically targetable alterations, especially in those patients with PDL-1 \<50%.

This trial is important because it seeks to discover whether the responses seen in first line treatments with PD-1 inhibitors + chemotherapy can be augmented with the addition of GM-CSF during the maintenance phase with pembrolizumab +/- pemetrexed.

Conditions

  • Advanced Lung Non-Small Cell Carcinoma
  • Non-Small Cell Carcinoma of Lung, TNM Stage 4

Interventions

DRUG

Granulocyte-Macrophage Colony-Stimulating Factor

250 mcg

DRUG

Pembrolizumab

200mg every 3 weeks

DRUG

pemetrexed

500mg/m2

DRUG

Paclitaxel

200mg/m2

DRUG

Carboplatin

AUC 5/6

Sponsors & Collaborators

  • Partner Therapeutics, Inc.

    collaborator INDUSTRY

  • Tufts Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2024-12-06
Completion
2024-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04856176 on ClinicalTrials.gov