18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy of Pembrolizumab Re-challenge Measured by Overall SurvivalPrimary· From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
Overall survival: Defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
Group
Value
95% CI
Cohort 1
9.4
1 – 18
Cohort 2
19.1
3 – 48
Efficacy of Pembrolizumab Re-challenge Measured by Progression Free Survival (PFS) Per RECIST v1.1.Secondary· From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
PFS: Defined as the length of time from the date of randomization to the date of the first documented progression of disease. "Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
Group
Value
95% CI
Cohort 1
1.6
0 – 11
Cohort 2
4.1
0.2 – 18
Best Global ResponseSecondary· From the date of randomization until end of follow up, up to 36 months
To evaluate the best global response of the treatment as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Complete response
Group
Value
95% CI
Cohort 1
0
Cohort 2
0
Partial response
Group
Value
95% CI
Cohort 1
1
Cohort 2
3
Stable disease
Group
Value
95% CI
Cohort 1
24
Cohort 2
11
Progression disease
Group
Value
95% CI
Cohort 1
25
Cohort 2
3
Not evaluable
Group
Value
95% CI
Cohort 1
5
Cohort 2
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were assessed an average of 30 months. Deaths were assessed up to 48 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Exploratory phase II trial of intravenous (IV) Pembrolizumab MK-3475 as second or further line with advanced Non-small cell Lung Cancer (NSCLC) who have failed to a prior treatment with anti-PDL1 drug.
Pembrolizumab 200 mg ,Q3W, IV infusion, Day 1 of each 3 week cycle will be administered until disease progression.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
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Other Spanish Lung Cancer Group trials
Trials by the same sponsor.
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· completed
NCT03526900 — Atezolizumab in Combination With Carboplatin Plus Pemetrexed in Chemotherapy-naïve Patients With Asymptomatic Brain Meta
· Phase 2
· completed
NCT03496766 — Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS
· Phase 2
· terminated
NCT03363139 — T790M Mutation Testing in Blood by Different Methodologies
· completed
NCT03132493 — Nivolumab in the Real World: Analysis of the Expanded Use in Spanish Patient
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spanish Lung Cancer Group
Last refreshed: 24 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03526887.