Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer

Last updated: June 4, 2024
Sponsor: Hunan Province Tumor Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab

Clinical Study ID

NCT05284539
20220117
  • Ages > 18
  • All Genders

Study Summary

The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Understand the requirements and contents of the clinical trial, and provide a signedand dated informed consent form.

  2. Age ≥ 18 years.

  3. Histologically or cytologically confirmed, Stage IV NSCLC.

  4. EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory,progressed from first line systematic therapy.

  5. ECOG 0-1.

  6. Predicted survival ≥ 12 weeks.

  7. Adequate bone marrow hematopoiesis and organ function

  8. Presence of measurable lesions according to RECIST 1.1.

Exclusion

Exclusion Criteria:

Cancer-Specific Exclusions:

  • Active or untreated central nervous system metastases.

  • Malignancies other than NSCLC within 5 years prior to randomization, with theexception of those with a negligible risk of metastasis or death treated withexpected curative outcome.

General Medical Exclusions:

  • Pregnant or lactating women.

  • History of autoimmune disease.

  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screeningchest computed tomography scan. History of radiation pneumonitis in the radiationfield (fibrosis) is permitted.

  • Positive test for human immunodeficiency virus.

  • Active hepatitis B or hepatitis C.

  • Severe infection within 4 weeks prior to randomization.

  • Significant cardiovascular disease.

  • Illness or condition that interferes with the participant's capacity to understand,follow and/or comply with study procedures.

Exclusion Criteria Related to Medications:

• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.

Study Design

Total Participants: 760
Treatment Group(s): 1
Primary Treatment: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab
Phase: 2
Study Start date:
April 01, 2022
Estimated Completion Date:
October 10, 2027

Study Description

The investigators want to evaluate the Efficacy and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.

This study will be divided into three cohorts. Cohort A for EGFR mutation NSCLC, Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included.

Cohort B for ALK fusion NSCLC, Patient with NGS identified ALK fusion NSCLC who failed from first line Alectinib/Lorlatinib/Ceritinib/Ensartinib/Brigatinib will be included. All the patients will be divided two group,3'ALK and 3'ALK with retention of 5'ALK.

Cohort C for ROS1 fusion NSCLC, Patient with NGS identified ROS1 fusion NSCLC who failed from first line Crizotinib/Entrectinib/Ensartinib/Brigatinib will be included.

The investigators will collect the safety and efficacy data for all the patients.

The tissue and blood samples will be collected under the permission of the participate.

Single cell sequencing, DSP, RNA-seq and IHC will be performed to evaluate the TME.

Connect with a study center

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

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