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NCT05271916

First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

Recruiting now Phase 1, PHASE2 Last updated 19 April 2023
What this trial tests

Phase 1, PHASE2 trial testing Dacomitinib+Anlotinib in Non-Small Cell Lung Cancer (NSCLC) in 140 participants. Currently enrolling.

Timeline
13 October 2022
Primary endpoint
1 January 2025
1 May 2027

Quick facts

Lead sponsorShanghai Chest Hospital
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment140
Start date13 October 2022
Primary completion1 January 2025
Estimated completion1 May 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Chest Hospital

Who can join

Adults 18 to 75, any sex, with Non-Small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open label, Phase I/IIB study investigating the efficacy and safety of treatment with dacomitinib plus anlotinib as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) 21-L858R mutations. This study comprises two parts: 1. A dose escalation Phase I study to determine the recommended phase II dose. 2. a multi-center, open label, randomized controlled, Phase IIB study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. New Generations of Tyrosine Kinase Inhibitors in Treating NSCLC with Oncogene Addiction: Strengths and Limitations.
    Attili I, Corvaja C, Spitaleri G, Del Signore E, et al · · 2023 · cited 32× · PMID 37894445 · DOI 10.3390/cancers15205079

Verify or expand the search:

Other recruiting trials for Non-Small Cell Lung Cancer (NSCLC)

Currently open trials in the same condition.

Other Shanghai Chest Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT05271916.

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