CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 230 target
Drug / intervention
Pembrolizumabdrug
Likely dose
Not stated in record
Key inclusion· 19
  • Histologically or cytologically confirmed metastatic NSCLC or stage III not candidates for surgery/chemoradiation
  • EGFR and ALK mutation-negative disease
  • PD-L1 TPS ≥50% or lower with prior single agent pembrolizumab per guidelines
  • Screening ctDNA drawn after registration, within 2 cycles of Q3W or 1 cycle of Q6W pembrolizumab
Key exclusion· 7
  • Large Cell Neuroendocrine Carcinoma (LCNEC)
  • Symptomatic CNS metastases or CNS metastases requiring immunosuppressive corticosteroids >10 mg/day prednisone equivalents
  • Not suitable candidates for pembrolizumab per Product Monograph/Drug Label including active infection, autoimmune disease, immunosuppressive therapy requirements, severe immune-mediated adverse reactions, hypersensitivity
  • Contraindications to platinum combination chemotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04093167
NCT04093167Phase 2RecruitingHigh Momentum
Long Recruiting

A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer

Canadian Cancer Trials Group·interventional·Posted Sep 17, 2019·Updated Jun 9, 2026

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab for Lung Cancer. Currently recruiting, targeting 230 participants across 11 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed Summary

The standard or usual treatment for this disease is pembrolizumab given by needle into the veins (IV). Some cancers shed DNA (circulating tumour DNA or ctDNA) or genes (biomarkers) into the blood, and levels of these biomarkers may be able to tell researchers how people respond to treatment with pembrolizumab before they feel worse, or the cancer is worse on imaging tests. Researchers are studying how levels of these biomarkers can show how cancers are responding to treatment and whether adding chemotherapy to pembrolizumab based on detection of ctDNA can offer better results.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States

Timeline

Phase 2Recruiting
20202021202220232024202520262027
First PostedSep 17, 2019
Enrollment StartMay 26, 2020
Primary CompletionDec 31, 2026
Study CompletionJul 30, 2027
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 6.8 years agoPrimary completion in 6 months

Arms & Interventions

Pembrolizumab aloneactive_comparator

Drug: Pembrolizumab
Pembrolizumab + standard platinum-based chemotherapyexperimental

Drug: Pembrolizumab

Interventions

Pembrolizumabdrug

Per current Product Monograph/U.S. Drug Label and/or local guidelines.