PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy. Eligible patients will be treated with the study drug until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione Ricerca Traslazionale
• Collaborators: Clinical Research Technology S.r.l.; Clinical research technology Srl
• Treatments: Crizotinib

Criteria

Inclusion Criteria:

1. Written informed consent;

2. Male or female patient ages ≥ 18 years;

3. Histologically/cytologically confirmed diagnosis of NSCLC with evidence of ROS1 rearrangement;

4. Possibility to perform a new tumor biopsy or tumor tissue collected at the time or after crizotinib failure;

5. Patient pretreated with crizotinib with evidence of disease progression during crizotinib therapy;

6. At least one radiological measurable disease according to RECIST criteria;

7. At least 1 previous standard chemotherapy regimen;

8. Performance status 0-2 (ECOG);

9. Patient compliance to trial procedures

10. Adequate bone marrow function (ANC ≥ 1.5x109/L, platelets ≥ 100x109/L, haemoglobin > 9 g/dl);

11. Adequate liver function (bilirubin < grade 2, transaminases no more than 3xULN/<5xULN in present of liver metastases);

12. Normal level of alkaline phosphatase and creatinine;

13. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method [intrauterine contraceptive device (IUD), birth control pills, or barrier device] during and for ninety (90) days after end of treatment.

Exclusion Criteria:

1. No ROS1 rearrangement 2. No previous therapy with crizotinib; 3. No evidence of crizotinib failure; 4. No post-crizotinib tumor tissue available; 5. Absence of any measurable lesions; 6. No previous chemotherapy; 7. Concomitant radiotherapy or chemotherapy; 8. Symptomatic brain metastases; 9. Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin; 10. Predisposing factors for acute pancreatitis (e.g., uncontrolled hyperglycaemia, current gallstone disease, alcoholism); 11. History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis (but not history of prior radiation pneumonitis); 12. Pregnancy or lactating female; 13. Other serious illness or medical condition potentially interfering with the study.

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