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

NCT04856176 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: GM-CSF
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Progression free survival (PFS)

  Progression is measured according to RECIST 1.1 criteria.

  24 Months

• Overall Survival (OS)

  Patient survival status throughout their participation in the study

  24 months

Secondary Outcomes (6)

• To evaluate changes in monocytes at different time points during study treatment

  24 Months

• To evaluate changes in myeloid derived suppressor cells at different time points during study treatment

  24 Months

• To evaluate changes in CD4 T at different time points during study treatment

  24 Months

• To evaluate changes in CD8 T at different time points during study treatment

  24 Months

• To evaluate changes in PD-1+ CD4 at different time points during study treatment

  24 Months

Study Arms (1)

GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed

EXPERIMENTAL

All patients will receive GM-CSF plus maintenance pembrolizumab with or without pemetrexed, following completion of 4 cycles of chemo-immunotherapy

Drug: Granulocyte-Macrophage Colony-Stimulating Factor; Drug: Pembrolizumab; Drug: pemetrexed; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor DRUG

250 mcg

GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed

Pembrolizumab DRUG

200mg every 3 weeks

GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed

pemetrexed DRUG

500mg/m2

GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed

Paclitaxel DRUG

200mg/m2

GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed

Carboplatin DRUG

AUC 5/6

GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically confirmed stage 4 NSCLC or stage 3B/3C not able to receive chemoradiation with no sensitizing EGFR or ALK mutations.
• PDL-1 of 1%-49%
• No previous history of immunotherapy treatment
• ECOG PS 0-1
• At least one measurable lesion according to RECIST version 1.1
• Life expectancy of at least 3 months.
• Able to self-administer daily GM-CSF injections
• Eligible for treatment with 4 cycles of chemoimmunotherapy followed by maintenance therapy with pembrolizumab +/- pemetrexed.

You may not qualify if:

• Receiving systemic glucocorticoids or other immunosuppressive treatment
• Untreated brain metastases
• Active autoimmune disease
• Active interstitial lung disease, pneumonitis
• Solid organ transplant recipients
• Subject may not participate in another drug research study while participating in this research study
• Pregnant patients
• Known hypersensitivity to GM-CSF (sargramostim)

Sponsors & Collaborators

• Tufts Medical Center: lead
• Partner Therapeutics, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; pembrolizumab; Pemetrexed; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Phase II open-label, single-center, single arm trial using a Simon two-stage optimal design.

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: January 3, 2022
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

US (1)