Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    120
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 11 September 2021
Investigator
Daiichi Sankyo Contact for Clinical Trial Information
Primary Contact
Showa Univeristy Hospital (3.4 mi away) Contact
+23 other location

Summary

This study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in participants with advanced or metastatic non-small cell lung cancer.

Description

The primary objective of this study will assess safety and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without 4 cycles of platinum chemotherapy in participants with advanced or metastatic NSCLC who have either been previously treated or are treatment nave in a metastatic setting.

Two dose levels of Dato-DXd (4.0 mg/kg and 6.0 mg/kg) will be studied in combination with 200 mg fixed-dose pembrolizumab in 6 study cohorts. This study will be conducted sequentially and dose escalation will occur according to lower dose to higher dose in the same combination regimen (4.0 mg/kg to 6.0 mg/kg) and from 2-drug combination (Dato-DXd and pembrolizumab) to 3-drug combination regimen (Dato-DXd, pembrolizumab, and carboplatin or cisplatin).

Details
Condition Advanced or Metastatic NSCLC
Treatment cisplatin, carboplatin, Pembrolizumab, DS-1062a, Datopotamab deruxtecan
Clinical Study IdentifierNCT04526691
SponsorDaiichi Sankyo, Inc.
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced or metastatic NSCLC, histologically confirmed at diagnosis of NSCLC, documented negative test results for EGFR and ALK genomic alterations, and no known genomic alterations in ROS1, NTRK, BRAF, RET, MET, or other driver oncogenes with approved therapies (actionable genomic alterations)
Is not a candidate for surgical resection or chemoradiation with curative intent
Documentation of radiological disease progression while on or after receiving the most recent treatment regimen, if any, for advanced or metastatic NSCLC
Must meet the following prior therapy requirements for advanced or metastatic NSCLC
Dose escalation (all cohorts): Has received 2 lines of prior anticancer therapy for locally advanced or metastatic NSCLC
Willing and able to undergo a mandatory tumor biopsy
Archival tumor tissue from initial diagnosis, to the extent that archival tumor tissue is available, for measurement of TROP2 expression levels or other biomarkers
Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with 200 mg fixed dose of pembrolizumab): Has not received PD-1/PD-L1, PD-L2, CTLA-4 directed immunotherapy and may or may not have been treated with systemic chemotherapy for advanced or metastatic NSCLC
Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 Day 1
Dose expansion (cohorts with 4.0 mg/kg or 6.0 mg/kg Dato-DXd in combination with 200 mg fixed dose of pembrolizumab and 4 cycles of AUC 5 carboplatin or cisplatin 75 mg/m^2): Has not been treated with systemic anticancer therapy for advanced or metastatic NSCLC

Exclusion Criteria

Received a live vaccine within 30 days prior to the first dose of study treatment
Active, known, or suspected autoimmune disease
Experienced grade 3 or higher immune-related adverse events (AEs) with prior treatment of anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 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)
Prior organ transplantation, including allogeneic tissue or solid organ transplantation
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
Concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications, except for managing AEs
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Has a history of malignancy, other than NSCLC, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for 3 years
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