NCT01931306 is a clinical trial of Afatinib in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT01931306?

NCT01931306 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT01931306?

Interventions in NCT01931306: Afatinib.

What condition does NCT01931306 study?

NCT01931306 studies Carcinoma, Non-Small-Cell Lung.

Is NCT01931306 still recruiting?

NCT01931306 is currently approved for marketing. Last updated 14 November 2018.

Last reviewed 2018-11-14 · How we verify

NCT01931306

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC)

APPROVED FOR MARKETING Last updated 14 November 2018

What this trial tests

trial testing Afatinib in Carcinoma, Non-Small-Cell Lung. Approved for marketing.

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	APPROVED FOR MARKETING
Study type	EXPANDED_ACCESS
Sites	8 locations across South Korea

Drugs / interventions tested

Afatinib (afatinib) — full drug profile →

Conditions studied

Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Boehringer Ingelheim — full company profile →

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

To provide expanded access and to evaluate the safety, tolerability and efficacy of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR tyrosine kinase inhibitor (TKI)

Publications & conference data

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

Recent advances in personalized lung cancer medicine.
Okimoto RA, Bivona TG. · · 2014 · cited 18× · PMID 25506379 · DOI 10.2217/pme.14.19
Afatinib in EGFR TKI-Naïve Patients with Locally Advanced or Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer: A Pooled Analysis of Three Phase IIIb Studies.
Passaro A, de Marinis F, Tu HY, Laktionov KK, et al · · 2021 · cited 13× · PMID 34307179 · DOI 10.3389/fonc.2021.709877
An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naïve patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations.
Park K, Kim JS, Kim JH, Kim YC, et al · · 2021 · cited 8× · PMID 34253172 · DOI 10.1186/s12885-021-08445-9

Verify or expand the search:

Other trials of Afatinib

Trials testing the same drug.

NCT07040956 — A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neo · Phase 2 · recruiting
NCT07010120 — A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head · Phase 1, PHASE2 · recruiting
NCT06804850 — Neoadjuvant Radiotherapy Plus Targeted Therapy and Immunotherapy vs. Targeted Therapy Plus Immunotherapy in Resectable H · Phase 2 · withdrawn
NCT06741982 — A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy an · Phase 1 · recruiting
NCT06494189 — Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable · Phase 1 · completed

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

Currently open trials in the same condition.

NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
NCT07222566 — Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adu · Phase 3 · recruiting
NCT07230691 — A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-Wor · recruiting
NCT07509333 — MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients · NA · recruiting
NCT07180862 — A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants · Phase 1 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01931306 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 14 November 2018

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/NCT01931306.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing