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NCT03727724: AFACET

Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer

Completed Phase 2 Last updated 18 October 2023
What this trial tests

Phase 2 trial testing Afatinib in Carcinoma, Non-Small-Cell Lung in 37 participants. Completed in 6 September 2022.

Timeline
4 December 2018
Primary endpoint
6 September 2022
6 September 2022

Quick facts

Lead sponsorThe Netherlands Cancer Institute
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment37
Start date4 December 2018
Primary completion6 September 2022
Estimated completion6 September 2022
Sites4 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

The Netherlands Cancer Institute

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single arm open-label multi-center phase II study, investigating disease control rate after 18 weeks of treatment with afatinib/cetuximab combination therapy in patients with advanced non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting <i>EGFR</i> exon 20 insertion mutations in non-small cell lung cancer.
    Vyse S, Huang PH. · · 2019 · cited 262× · PMID 30854234 · DOI 10.1038/s41392-019-0038-9
  2. Targeting <i>EGFR</i> Exon 20 Insertions in Non-Small Cell Lung Cancer: Recent Advances and Clinical Updates.
    Meador CB, Sequist LV, Piotrowska Z. · · 2021 · cited 77× · PMID 34301786 · DOI 10.1158/2159-8290.cd-21-0226
  3. Variability of EGFR exon 20 insertions in 24 468 Chinese lung cancer patients and their divergent responses to EGFR inhibitors.
    Qin Y, Jian H, Tong X, Wu X, et al · · 2020 · cited 47× · PMID 32412152 · DOI 10.1002/1878-0261.12710
  4. EGFR exon 20 insertion mutations in advanced non-small-cell lung cancer: current status and perspectives.
    Hou J, Li H, Ma S, He Z, et al · · 2022 · cited 44× · PMID 35418149 · DOI 10.1186/s40364-022-00372-6
  5. The Right Partner in Crime: Unlocking the Potential of the Anti-EGFR Antibody Cetuximab <i>via</i> Combination With Natural Killer Cell Chartering Immunotherapeutic Strategies.
    Baysal H, De Pauw I, Zaryouh H, Peeters M, et al · · 2021 · cited 41× · PMID 34557197 · DOI 10.3389/fimmu.2021.737311
  6. Predictive and Prognostic Biomarkers for Lung Cancer Bone Metastasis and Their Therapeutic Value.
    Chai X, Yinwang E, Wang Z, Wang Z, et al · · 2021 · cited 36× · PMID 34722241 · DOI 10.3389/fonc.2021.692788
  7. Non-small Cell Lung Cancer with EGFR or HER2 Exon 20 Insertion Mutations: Diagnosis and Treatment Options.
    Brazel D, Kroening G, Nagasaka M. · · 2022 · cited 22× · PMID 36255589 · DOI 10.1007/s40259-022-00556-4
  8. Amivantamab for the treatment of &lt;i&gt;EGFR&lt;/i&gt; exon 20 insertion mutant non-small cell lung cancer.
    Vyse S, Huang PH. · · 2022 · cited 22× · PMID 34913823 · DOI 10.1080/14737140.2022.2016397

Verify or expand the search:

Other trials of Afatinib

Trials testing the same drug.

Other recruiting trials for Carcinoma, Non-Small-Cell Lung

Currently open trials in the same condition.

Other The Netherlands Cancer Institute 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/NCT03727724.

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