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NCT00525148
LUX Lung 2 A Phase II Single-arm Trial of BIBW 2992 in Non-small Cell Lung Cancer Patients With EGFR Activating Mutations
Phase 2 trial testing BIBW 2992 in Carcinoma, Non-Small-Cell Lung in 129 participants. Completed in 1 August 2015.
1 February 2010
Quick facts
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 129 |
| Start date | 1 August 2007 |
| Primary completion | 1 February 2010 |
| Estimated completion | 1 August 2015 |
| Sites | 30 locations across United States, Taiwan |
Drugs / interventions tested
- BIBW 2992 — 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
Adults 18 to 99, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Objective Response (OR) as Determined by RECIST 1.0
Time frame: Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.
Objective response (OR) was assessed for all treated patients by independent review as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. OR included complete response (CR) and partial response (PR), where CR or PR must have been confirmed by a subsequent response in ≥28 days.
Sponsor's own description
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only in stage 2) will be allowed to enter into the trial.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6.
Yang JC, Sequist LV, Geater SL, Tsai CM, et al · · 2015 · cited 772× · PMID 26051236 · DOI 10.1016/s1470-2045(15)00026-1 -
Acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancers dependent on the epidermal growth factor receptor pathway.
Nguyen KS, Kobayashi S, Costa DB. · · 2009 · cited 340× · PMID 19632948 · DOI 10.3816/clc.2009.n.039 -
Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial.
Yang JC, Shih JY, Su WC, Hsia TC, et al · · 2012 · cited 315× · PMID 22452895 · DOI 10.1016/s1470-2045(12)70086-4 -
Osimertinib for Patients With Non-Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09).
Cho JH, Lim SH, An HJ, Kim KH, et al · · 2020 · cited 271× · PMID 31825714 · DOI 10.1200/jco.19.00931 -
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 -
Current Landscape of Non-Small Cell Lung Cancer: Epidemiology, Histological Classification, Targeted Therapies, and Immunotherapy.
Rodak O, Peris-Díaz MD, Olbromski M, Podhorska-Okołów M, et al · · 2021 · cited 159× · PMID 34572931 · DOI 10.3390/cancers13184705 -
Clinical development of targeted and immune based anti-cancer therapies.
Seebacher NA, Stacy AE, Porter GM, Merlot AM. · · 2019 · cited 147× · PMID 30975211 · DOI 10.1186/s13046-019-1094-2 -
Therapeutic advances in non-small cell lung cancer: Focus on clinical development of targeted therapy and immunotherapy.
Cheng Y, Zhang T, Xu Q. · · 2021 · cited 81× · PMID 34977873 · DOI 10.1002/mco2.105
Verify or expand the search:
- PubMed search for NCT00525148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BIBW 2992
Trials testing the same drug.
- NCT02271906 — The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting · Phase 2 · terminated
- NCT01125566 — LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatmen · Phase 3 · completed
- NCT01121393 — BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) · Phase 3 · completed
- NCT00949650 — BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation · Phase 3 · completed
- NCT00950742 — Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-p · 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.
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT00525148 (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: 28 July 2016
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/NCT00525148.
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