Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC

NCT05894889 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ECT2304029302
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy following by pembrolizumab adjuvant in stage IIA-IIIB (N2) NSCLC participants without sensitizing EGFR/ALK mutation. The study will also investigate the role of CXCL13+PD1+ CD8 T cells in association with pathological response / resistance to neoadjuvant immunotherapy by comparing the proportion of CXCL13+PD1+ CD8 T cells in all CD8 T cells in post-treatment (surgical sample) between MPR group and non-MPR group.

Conditions

Stage IIIB(N2) Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer

Keywords

Early stage NSCLC, neoadjuvant, adjuvant, pembrolizumab

Outcome Measures

Primary Outcomes (2)

• pCR rate

  pCR in eligible stage IIA-IIIB (N2) NSCLC participants (AJCC Version 8, no known sensitizing EGFR or ALK alterations) following neoadjuvant pembrolizumab plus chemotherapy

  Up to approximately 16 months

• Post-treatment proportion of CXCL13+PD1+ CD8 T cells in all CD8 T cells

  Post-treatment proportion of CXCL13+PD1+ CD8 T cells in all CD8 T cells in single cell RNA-seq data

  Up to approximately 16 months

Secondary Outcomes (4)

• MPR in eligible stage IIA-IIIB (N2) NSCLC participants (AJCC Version 8, no known sensitizing EGFR or ALK alterations) following neoadjuvant pembrolizumab plus chemotherapy

  Up to approximately 16 months

• Event-free survival (EFS)

  Up to approximately 46 months

• Number of Participants with One or More Adverse Events

  Up to approximately 46 months

• PD-L1 TPS(Tumor Proportion Score) evaluation in pre-treatment patients

  Up to approximately 16 months

Study Arms (1)

Pembrolizumab + Chemotherapy

EXPERIMENTAL

Non-squamous NSCLC: pembrolizumab 200mg as at least 30-minute IV infusion on Day 1, followed by pemetrexed at a dose of 500mg/m2 IV over 30 minutes or per institutional standard with Carboplatin at a dose of AUC 5 over 120 minutes or per institutional standard, of a 3-week treatment cycle, for up to 4 cycles. Squamous NSCLC: pembrolizumab 200mg as at least 30-minute IV infusion on Day 1, followed by nab-paclitaxel at a dose of 135mg/m2 IV over 30 minutes or per institutional standard with Carboplatin at a dose of AUC 5 over 120 minutes or per institutional standard, of a 3-week treatment cycle, for up to 4 cycles. Nab-paclitaxel will also be administered at the dose of 135mg/m2 for over 30 minutes IV infusion or per institutional standard on day 8 of each 3-week treatment cycle.

Biological: Pembrolizumab 200 mg IV infusion

Interventions

Pembrolizumab 200 mg IV infusion BIOLOGICAL

Biological: Pembrolizumab 200 mg IV infusion Drug: nab-paclitaxel IV infusion Drug: Carboplatin IV infusion Drug: Pemetrexed IV infusion

Also known as: Drug: nab-paclitaxel IV infusion, Drug: Carboplatin IV infusion, Drug: Pemetrexed IV infusion

Pembrolizumab + Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of \[Stage II, IIIA or IIIB(N2) NSCLC (AJCC Version 8)\] will be enrolled in this study.
• Note: mixed cellularity tumors are allowed. tumor should be considered resectable in terms of surgeon's determinations before study entry by investigators. Lymph nodes disease are recommended to have pathological confirmation. A PET-CT may be utilized as a surrogate for pathologic staging by site's feasibility.
• Male participants:
• A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 1 year after the last dose of study treatment and refrain from donating sperm during this period.
• Female participants:
• A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
• A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least \[180 days after the last dose of carboplatin and for at least 120 days after the last dose of pembrolizumab, whichever occurs latest\].
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial and may also provide consent for future biomedical research.
• Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Participants suspected with secondary lung cancer (eg. ground glass nodules) were also eligible for this study (For solid nodules, biopsy, if available, should be performed in case of any intrapulmonary metastasis).
• Archival tumor tissue sample or newly obtained \[core, incisional or excisional\] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
• Have adequate organ function as defined in the following table. Specimens must be collected within 10 days prior to the start of study intervention.

You may not qualify if:

• Have confirmed sensitizing EGFR mutation or ALK alterations. Note: EGFR and ALK testing will be performed in local hospital, and do not need to be sent to the central laboratory.
• A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
• Has one of the following tumor locations/types:
• NSCLC involving the superior sulcus
• Large cell neuro-endocrine cancer
• Sarcomatoid tumor
• Has had an allogenic tissue/solid organ transplant.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
• Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to \[allocation\].
• Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
• Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
• Note: please refer to Section 5.5.2 for information on COVID-19 vaccines
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.

Sponsors & Collaborators

• Peking University: lead
• Merck Sharp & Dohme LLC: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (2)

Peking University

Beijing, Beijing Municipality, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Infusions, Intravenous

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)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: None(Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: January 30, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)