Actively Recruiting
A Multicenter Single-Arm Phase II Study Evaluating Platinum-Pemetrexed Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer with Extracranial Progression on Lorlatinib
Led by Centro di Riferimento Oncologico - Aviano · Updated on 2024-04-23
45
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the activity and safety of combining platinum-pemetrexed based chemotherapy with Lorlatinib in patients who have ALK positive Non-Small Cell Lung Cancer (NSCLC) that has progressed only outside the brain while on Lorlatinib treatment. This phase II, multicenter, single-arm study focuses on patients with extracranial progression despite Lorlatinib, aiming to understand how this combination may affect progression and survival. Treatment begins with an induction phase of four cycles using Lorlatinib plus either Carboplatin or Cisplatin and Pemetrexed chemotherapy. After this, patients who show disease response or stability based on imaging scans enter a maintenance phase where they receive pemetrexed and Lorlatinib every 21 days. This maintenance continues until disease progression, unacceptable side effects, death, or withdrawal from the study. Participants will undergo regular assessments including CT and MRI scans to measure tumor response and monitor for progression. Researchers will evaluate progression-free survival as the primary outcome, along with intracranial progression-free survival, overall survival, and safety over up to 60 months. The study includes monitoring organ functions and treatment tolerability throughout the induction and maintenance phases, with continuous follow-up until the study ends or participants leave.
CONDITIONS
Brief Title
A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed stage IV ALK positive Non-Small Cell Lung Cancer
- Disease progressing outside the brain while on Lorlatinib treatment
- Age 18 years or older at informed consent
- ECOG performance status of 0 or 1
- Measurable disease by CT and MRI scans according to RECIST 1.1
- Radiologically confirmed multiple extracranial progression without central nervous system progression
- Adequate kidney, bone marrow, and liver function
- Estimated life expectancy of at least 3 months
- Agreement to use effective contraception during treatment and for at least 6 months after last dose if of childbearing potential
You will not qualify if you...
- Known allergy to any drugs or substances used in this study
- Diagnosis of another cancer within the last 3 years except certain treated skin, cervical, or prostate cancers
- Unsuitable for chemotherapy plus Lorlatinib combination as judged by investigator
- Toxicities preventing continuation of Lorlatinib therapy
- Use of strong CYP3A4/5 inducer medications
- Other exclusion criteria as determined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction phase of four cycles followed by maintenance phase in 21-day cycles until progression or discontinuation
Participants receive an induction phase of platinum-pemetrexed based chemotherapy plus Lorlatinib for four cycles. Those with response or stable disease then continue with a maintenance phase of pemetrexed plus Lorlatinib in 21-day cycles until disease progression, unacceptable toxicity, death, or withdrawal of consent.
Visits every 21 days during treatment cycles
Trial Site Locations
Total: 9 locations
1
Centro di Riferimento Oncologico (CRO) IRCCS
Aviano, Italy, 33081
Actively Recruiting
2
Azienda Ospedaliero-Universitaria Careggi Oncologia Medica
Florence, Italy, 50134
Not Yet Recruiting
3
Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia
Lido di Camaiore, Italy, 55049
Not Yet Recruiting
4
Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori"
Meldola, Italy, 47014
Not Yet Recruiting
5
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Not Yet Recruiting
6
IOV Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Not Yet Recruiting
7
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43126
Not Yet Recruiting
8
Azienda Ospedaliera di Perugia
Perugia, Italy, 06129
Not Yet Recruiting
9
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine, Italy, 33010
Not Yet Recruiting
Research Team
A
Alessandra Bearz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here