MET Exon 14 Atlama Mutasyonu Taşıyan İlerlemiş Küçük Hücreli Dışı Akciğer Kanseri Olan Çinli Yetişkin Hastalarda Capmatinib Çalışması

Sade dilde özet

Bu çalışma, MET exon 14 atlama mutasyonu taşıyan ilerlemiş küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) olan Çinli yetişkin hastalarda Capmatinib adlı ilacı değerlendirmiştir. Çalışmaya, 18 yaş ve üzeri, EGFR mutasyonu ve ALK yeniden düzenlenmesi olmayan, daha önce tedavi almamış veya tedavi görmüş hastalar katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Novartis Pharmaceuticals

Müdahale

Capmatinib

Başlangıç

17.05.2021

Tahmini bitiş

22.05.2025

Ülkeler

China

İlgili genler

Merkezler

• Xiamen, China
• Foshan, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Harbin, China
• Zhengzhou, China
• Wuhan, China
• Shenyang, China
• Jinan, China
• Shanghai, China
• Chengdu, China
• Kunming, China
• Hangzhou, China
• Beijing, China
• Shanghai, China
• Tianjin, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Key Inclusion Criteria:

* Chinese adult ≥ 18 years old at the time of informed consent
* Histologically confirmed stage IIIB, IIIC or IV NSCLC at the time of study entry, not amenable to curative surgery or radiation or multi-modality therapy (according to staging definition in CSCO guidelines for primary lung cancer, 2019).
* Histologically or cytologically confirmed diagnosis of NSCLC that is:

  1. EGFR wt: The EGFR wt status assessed as part of standard of care (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations)
  2. AND ALK rearrangement negative: assessed as part of standard of care by validated test
  3. AND either:

Cohort 1: Treatment naive participants with MET mutations, or Cohort 2: Pre-treated participants with MET mutations

* Cohort 1: participants must not have received any systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC). Neo-adjuvant and adjuvant systemic therapies will not count as one prior line of treatment if relapse occurred \> 12 months from the end of the neo-adjuvant or adjuvant systemic therapy.
* Cohort 2: participants must have failed one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB, IIIC or IV NSCLC).
* At least one measurable lesion according to RECIST v1.1.
* Adequate organ function
* ECOG performance status (PS) ≤1

Key Exclusion Criteria:

* Prior treatment with any MET inhibitor or HGF-targeting therapy.
* Known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines.
* Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* Presence or history of interstitial lung disease or interstitial pneumonitis, including, clinically significant radiation pneumonitis affecting activities of daily living or requiring therapeutic intervention.
* Substance abuse, active infection (including active hepatitis B and C, participants whose disease is controlled under antiviral therapy are eligible, and human immunodeficiency virus (HIV) history positive) or other severe, acute, or chronic medical or psychotic conditions or laboratory abnormalities that in the opinion of the investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results.