Tracking T-Cell Responses to Evaluate Pembrolizumab Effectiveness in Advanced Non-Small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-04-30

Brief Summary

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This study includes patients with advanced non-small cell lung cancer (NSCLC) - either unresectable stage III or stage IV adenocarcinoma without actionable driver mutations - who are treated with pembrolizumab in combination with platinum-based doublet chemotherapy, irrespective of PD-L1 expression levels.

The primary objective is to assess treatment response through integration of serial T-cell receptor (TCR) repertoire sequencing (Rep-seq), capturing longitudinal changes in T-cell clonality and diversity. These immune dynamics will be correlated with radiographic response assessed by RECIST 1.1, with the aim of improving the accuracy of response classification, including differentiation between progression, pseudo-progression, and hyperprogression.

Additionally, circulating tumor DNA (ctDNA) levels will be measured longitudinally (pre-treatment and during treatment) to evaluate their potential as a complementary biomarker of disease burden and treatment efficacy in the context of chemo-immunotherapy.

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Detailed Description

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Conditions

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NSCLC (Advanced Non-small Cell Lung Cancer) NSCLC Stage IV Without EGFR/ALK Mutation NSCLC Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pembrolizumab 200 mg combined with pemetrexed and platinum (cisplatin or carboplatin)

Group Type EXPERIMENTAL

Pembrolizumab (KEYTRUDA®)

Intervention Type DRUG

IV Pembrolizumab 200 mg combined with pemetrexed and platinum (investigator's choice of cisplatin or carboplatin) every 3 weeks

Interventions

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Pembrolizumab (KEYTRUDA®)

IV Pembrolizumab 200 mg combined with pemetrexed and platinum (investigator's choice of cisplatin or carboplatin) every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of NSCLC adenocarcinoma stage IV or unresectable stage III.
* Have measurable disease based on RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Adequate organ function.

Exclusion Criteria

* Aberration in one or more of molecular drivers.
* Has received prior systemic anti-cancer therapy prior to allocation.
* Known active CNS metastases and/or carcinomatous meningitis.
* Known additional malignancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No