A+C in Metastatic Lung Adenocarcinoma Cancer

NCT02946359 | Unknown Phase 2 DMC

• 1 other identifier: CAMAR01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase II, prospective, single arm, non comparative study with crizotinib combined with bevacizumab in treatment-naive lung adenocarcinoma cancer patients with ALK translocation or ROS1 translocation or MET amplification

Conditions

Lung Adenocarcinoma Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months

Secondary Outcomes (3)

• Overall Survival (OS)

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months

• Response rate in patients with ALK translocation or ROS1 translocation or MET amplification

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months

• Toxicity analysis: Incidence of Grade 3-4 Grade Toxicity graded according to National Cancer

  From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 100 months

Study Arms (3)

Patients with ALK translocation

EXPERIMENTAL

Treatment-naive lung adenocarcinoma cancer patients with ALK translocation with locally advanced or metastatic lung adenocarcinoma cancer and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal

Drug: Crizotinib, bevacizumab

Patients with ROS1 translocation

EXPERIMENTAL

Treatment-naive lung adenocarcinoma cancer patients with ROS1 translocation with locally advanced or metastatic lung adenocarcinoma cancer and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal

Drug: Crizotinib, bevacizumab

Patients with MET amplification

EXPERIMENTAL

Treatment-naive lung adenocarcinoma cancer patients with MET amplication with locally advanced or metastatic lung adenocarcinoma cancer and with at least one measurable tumor lesion will be considered eligible for the trial and they will receive crizotinib 250 mg BID p.o combined with bevacizomab 7.5mg/kg every three weeks until disease progression, unacceptable toxicity or patient refusal

Drug: Crizotinib, bevacizumab

Interventions

Crizotinib, bevacizumab DRUG

Eligible patients with ALK translocation or ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID and bevacizumab at the dose of 7.5mg/kg every three weeks. The dose of crizotinib and bevacizumab may be adjusted depending on the type and severity of toxicity encountered

Also known as: XALKORI,AVASTIN

Patients with ALK translocation; Patients with MET amplification; Patients with ROS1 translocation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of lung adenocarcinoma cancer
• Availability of tumor tissue for ROS1, ALK, MET analyses
• EGFR was wild type, positive for ROS1 translocation or ALK translocation or MET amplification
• At least one radiological measurable disease according to RECIST criteria (Response Evaluation Criteria in Solid Tumors )
• Patient didn't received any therapy for lung cancer before except surgery or radiotherapy, or the adjuvant chemotherapy had stopped for more than 12 months
• Performance status 0-2 (ECOG)
• Patient compliance to trial procedures
• age ≥ 18 years
• Written informed consent
• Adequate BM function (ANC ≥ 1.5x109/L, Platelets ≥ 100x109/L, HgB \> 9g/dl)
• Adequate liver function (bilirubin \<G2, transaminases no more than 3xULN/\<5xULN in present of liver metastases).
• Normal level of alkaline phosphatase and creatinine.
• 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.

You may not qualify if:

• Patients with EGFR mutation
• No tumor tissue available or patient negative for ALK translocation or ROS1 translocation or MET amplification
• Absence of any measurable lesion
• Prior therapy with bevacizumab or ipilimumab
• Symptomatic brain metastases
• Previous radiotherapy on the target lesion(s). If all sites were included in radiotherapy fields patient is eligible only if there is evidence of progressive disease after completion of radiotherapy.
• 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
• Pregnancy or lactating
• Other serious illness or medical condition potentially interfering with the study
• Significant known vascular disease
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure or significant traumatic injury within 28 days prior to study enrollment
• Serious, non-healing wound, ulcer or bone fracture
• Proteinuria at screening

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

PLA general hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

Crizotinib; Bevacizumab

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of oncology department

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 27, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: July 1, 2018
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CN (2)