A Phase 3, multicenter, randomized, open-label trial to compare the efficacy and safety of pembrolizumab (MK-3475) in combination with lenvatinib (E7080/MK-7902) versus docetaxel in previously treated participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and immunotherapy (LEAP-008)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501439-18-00

Acronym

MK-7902-008

Enrollment

206

Registered

2023-06-29

Start date

2019-06-26

Completion date

2024-08-22

Last updated

2024-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC with squamous or nonsquamous histology

Brief summary

Overall Survival (OS), Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Detailed description

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel, Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy, Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Number of Participants Experiencing an Adverse Event (AE), Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE), Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score, Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score, Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score, Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score, Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score, Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score, Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score

Interventions

DRUGLenvatinib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGDOCETAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS), Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel, Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy, Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Number of Participants Experiencing an Adverse Event (AE), Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE), Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score, Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score, Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score, Change from Baseline in EORTC QLQ-C30 Dyspnea (Ite	—

Measure

Time frame

—

Countries

France, Germany, Greece, Hungary, Italy, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026