Atezolizumab Plus Bevacizumab in First Line NSCLC Patients (TELMA)
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|ClinicalTrials.gov Identifier: NCT03836066|
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Atezolizumab-Bevacizumab||Phase 2|
Chemotherapy-naïve patients high-intermediate TMB (TMB≥10 mutations/MB) and with locally advanced or metastatic non-squamous non-small cell lung cancer patients will be selected. Enroled patientswill receive 1200 mg of atezolizumab and 15mg/Kg of Avastin® (bevacizumab) administered by IV infusion every 21 days (+/- 3 days).
The treatment will start within 1-5 days from enrolment. Atezolizumab may continue beyond disease progression per RECIST v1.1 until loss of clinical benefit, unacceptable toxicity, patient or physician decision to discontinue , or death. Bevacizumab will be administered until progression disease, unacceptable toxicity, patient or physician decision to discontinue or death.
For all patients, tumour response data collection will continue until disease progression, even if the patient stops study treatment prior to disease progression.
The primary endpoint is to evaluate the efficacy of Atezolizumab in combination with Bevacizumab as measured by Progression Free Survival according to RECIST Version 1.1.
PFS after enrolment is defined as the time from enrolment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Patient accrual is expected to be completed within 1.5 years excluding a run-in-period of 46 months. Treatment and follow-up are expected to extend the study duration to a total of 4.5 years. Patients will be followed 1.5 years after the end of treatment independently of the cause of end of treatment. The study will end once survival follow-up has concluded.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Open Label Study of Atezolizumab in Combination With Bevacizumab as First Line Treatment for Locally Advanced or Metastasic High-intermediate Tumor Mutation Burden Selected Non-squamous Non-small Cell Lung Cancer (NSCLC) Patients.|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||October 15, 2020|
|Estimated Study Completion Date :||October 15, 2023|
Experimental: Experimental: Atezolizumab plus Bevacizumab arm
1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.
Atezoluzumab 1200 mg + Bevacizumab 15 mg / kg
Other Name: Tecentriq-Avastin
- Efficacy of Atezolizumab in combination with Bevacizumab [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]To evaluate the efficacy of Atezolizumab in combination with Bevacizumab as measured by Progression Free Survival according to Response Evaluation Criteria in Solid Tumours (RECIST).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836066
|Contact: Eva Pereirafirstname.lastname@example.org|
|Principal Investigator:||Mariano Provencio, PhD||Hospital Universitario Puerta de Hierro|