Atezolizumab Plus Bevacizumab in First Line NSCLC Patients

NCT03836066 | Completed Phase 2 Results

• 2 other identifiers: GECP 18/03_TELMA2018-004654-17
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 25

Brief Summary

This is a multi-center phase II clinical trial of atezolizumab in combination with bevacizumab as first line treatment for locally advanced or metastasic high-intermediate tumour mutation burden selected NSCLC patients. 102 patients will be enrolled in this trial to examine the efficacy of this combination measured by progression free survival according to response evaluation Criteria in solid tumours (RECIST) version 1.1.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC, Atezolizumab, Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Efficacy of Atezolizumab in Combination With Bevacizumab - PFS

  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).

  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

Study Arms (1)

Experimental: Atezolizumab plus Bevacizumab arm

EXPERIMENTAL

1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.

Drug: Atezolizumab-Bevacizumab

Interventions

Atezolizumab-Bevacizumab DRUG

Atezoluzumab 1200 mg + Bevacizumab 15 mg / kg

Also known as: Tecentriq-Avastin

Experimental: Atezolizumab plus Bevacizumab arm

Eligibility Criteria

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

You may qualify if:

• Male or female, aged ≥ 18 years old
• ECOG performance status of 0 or 1.
• Histologically or cytologically confirmed, Stage IIIB or IV non-squamous NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology
• No prior treatment for Stage IIIB or IV non-squamous NSCLC.
• Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemo-radiotherapy.
• Patients with a treated asymptomatic CNS metastasis are eligible, provided they meet all of the following criteria:
• Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).
• No ongoing requirement for corticosteroids as therapy for CNS disease.
• No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to randomization.
• Patients with high-intermediate Tumour Mutational Burden analysed by Foundation Medicine (≥10 mutations/ MB) performed by a Foundation Medicine laboratory on previously obtained archival tumour tissue or tissue obtained from a biopsy at prescreening (sample must fulfil minimal sample requirements of 20% tumour cellularity and a minimum surface of 25mm2).
• Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease.
• Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to randomization:
• Neutrophils ≥ 1500 cells/μL without granulocyte colony-stimulating factor support.
• Lymphocyte count ≥ 500/μL.
• Platelet count ≥ 100,000/μL without transfusion.

You may not qualify if:

• Patients with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene.
• Patients with an anaplastic lymphoma kinase (ALK) fusion oncogene.
• Patients with an STK-1 Ligand alteration.
• Patients with MDM2 amplification.
• Patients with ROS1 translocations.
• Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \> 2 weeks prior to randomization.
• Leptomeningeal disease.
• Uncontrolled tumour-related pain. Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to initiation of study drug. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for locoregional therapy, if appropriate, prior to initiation of study drug.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX®) are allowed.
• Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or Ca \> 12 mg/dL or corrected serum calcium \> ULN).
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS \> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent).

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (25)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital General de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

ICO Badalona

Badalona, Barcelona, 08916, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08022, Spain

Location

Consorcio Hospitalario Provincial de Castelló

Castelló, Castelló, 12004, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Jaén, 23007, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Hospital La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

Location

Hospital Universitario Son Llàtzer

Palma de Mallorca, Mallorca, 07198, Spain

Location

Hospital General Universitario de Málaga

Málaga, Málaga, 29010, Spain

Location

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36036, Spain

Location

Complejo Hospitalario de Toledo

Toledo, Toledo, 45004, Spain

Location

Hospital Universitari i Politécnic La Fe

Valencia, Valencia, 46009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital General de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

Location

Related Publications (1)

• Provencio M, Ortega AL, Coves-Sarto J, Calvo V, Marse-Fabregat R, Domine M, Guirado M, Carcereny E, Fernandez N, Alvarez R, Blanco R, Leon-Mateos L, Sanchez-Torres JM, Sullivan IG, Cobo M, Sanchez-Hernandez A, Massuti B, Sierra-Rodero B, Martinez-Toledo C, Serna-Blasco R, Romero A, Cruz-Bermudez A. Atezolizumab Plus Bevacizumab as First-line Treatment for Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer With High Tumor Mutation Burden: A Nonrandomized Controlled Trial. JAMA Oncol. 2023 Mar 1;9(3):344-353. doi: 10.1001/jamaoncol.2022.5959.

  PMID: 36520426 DERIVED

Related Links

• Web page of the sponsor where users can find more information about Fundación GECP studies

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

No study limitations

Results Point of Contact

• Title: Eva Pereira
• Organization: Fundación GECP

gecp@gecp.org

+34 934302006

Study Officials

• Mariano Provencio, MD

  Hospital Universitario Puerta de Hierro

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: May 15, 2019
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (25)