Actively Recruiting
Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
Led by Instituto Oncológico Dr Rosell · Updated on 2024-04-03
32
Participants Needed
4
Research Sites
224 weeks
Total Duration
On this page
Sponsors
I
Instituto Oncológico Dr Rosell
Lead Sponsor
T
Turning Point Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase I study of repotrectinib in combination with osimertinib in patients with advanced or metastatic EGFR mutant non small cell lung cancer (NSCLC). The study will be conducted in 2 parts, Part Ia and Part Ib, and its purpose will be to find the incidence of dose-limiting toxicities (DLTs) as defined by the primary safety and tolerability endpoint. The Phase Ia study will also determine the impact of repotrectinib on osimertinib pharmacokinetics (PK) and the maximum tolerated dose (MTD), if reached, of repotrectinib given in combination with osimertinib and the recommended Phase II dose (RP2D). Dose escalation will be conducted according to a 'Rolling-6' based study design with 3 dose levels for repotrectinib: 80 mg once a day (QD), 160 mg QD or 160 mf QD during 14 days followed by 160 mg twice a day (BID); in combination with 80 mg QD of osimertinib. A total of 6 patients will be enrolled in each dose level cohort. In addition, this Phase Ib study will test early drug activity (efficacy) of the proposed combination treatment in an expansion cohort at the RP2D.
CONDITIONS
Official Title
Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosis of locally advanced or metastatic non-squamous cell lung carcinoma (NSCLC) not suitable for curative surgery or radiotherapy
- Stage IV disease or locally advanced disease without curative treatment options
- Locally diagnosed EGFR activating mutation confirmed by approved test
- ECOG performance status of 0 or 1
- Presence of measurable or evaluable disease as per RECIST 1.1
- Patients with asymptomatic CNS metastases or leptomeningeal carcinomatosis meeting specific steroid and treatment timing criteria
- Availability of tumor tissue samples obtained within 60 days before treatment start
- Life expectancy of at least 12 weeks
- Adequate blood cell counts, liver, and kidney function
- Ability to participate in all study procedures
- Prior chemotherapy or immunotherapy allowed with specified washout periods and resolved side effects
- Women of childbearing potential and male partners must agree to use effective contraception during and after the study
- Signed informed consent before study procedures
- For Part B only: progression after osimertinib without tertiary EGFR mutation or MET amplification, or progression after first or second generation EGFR inhibitors
You will not qualify if you...
- Prior treatment with repotrectinib
- Lung cancer subtypes other than adenocarcinoma or mixed types with squamous or small-cell components
- History of other primary cancers within 5 years except certain treated skin or in situ carcinomas
- Only one measurable tumor lesion previously resected or irradiated
- Presence of EGFR exon 20 insertion mutation
- Significant cardiovascular disease within 6 months, including specific cardiac disorders and abnormal ECG findings
- Active infections requiring treatment, including HIV
- Gastrointestinal diseases affecting drug absorption
- Peripheral neuropathy grade 2 or higher
- Severe interstitial lung disease or related lung conditions
- Other severe medical or psychiatric conditions that increase risk or interfere with study
- For Part B only: presence of tertiary EGFR mutation or MET amplification
- Use or anticipated need for strong CYP3A inhibitors or inducers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Hospital Regional Universitario de Málaga
Málaga, Andalusia, Spain, 29010
Actively Recruiting
2
Hospital Son Espases
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
3
Quiron Dexeus
Barcelona, Catalonia, Spain, 08018
Actively Recruiting
4
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
Research Team
A
A responsible person designated by the sponsor
CONTACT
R
Responsible person designated by the sponsor, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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