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Protocol # 19-368

Status

Recruiting

Description

Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.

Condition

  • Non-Small Cell Lung Cancer

Interventions

  • Osimertinib
  • Savolitinib
  • Gefitinib
  • Necitumumab
  • Durvalumab
  • Carboplatin
  • Pemetrexed
  • Alectinib
  • Selpercatinib
  • Selumetinib
  • Etoposide
  • Cisplatin
  • Datopotamab deruxtecan

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Objective response rate (ORR)

Secondary Outcome:

  • Progression-free survival (PFS)
  • Duration of response (DoR)
  • Overall survival (OS)
  • Plasma concentrations of therapeutic agents
  • Plasma concentrations of therapeutic agents
  • Incidence of Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as characterized and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5

Enrollment

250

Study Start Date

June 25, 2019

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     130 Years
  • Healthy volunteers:     No

Sponsors

AstraZeneca

Source

AstraZeneca

Official title

A Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy.

Clinicaltrials.gov Identifier

NCT03944772

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.