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Non Small Cell Lung CancerPhase 2TELMANCT03836066

Atezolizumab Plus Bevacizumab in First Line NSCLC Patients

A Phase 2 study testing Atezolizumab-Bevacizumab in people with Non Small Cell Lung Cancer, run by Fundación GECP at 25 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Atezolizumab-Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
25 sitesSpain
Study dates
15 May 2019to 21 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study. Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to inclusion, if all other criteria are met.
  • 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.
  • Haemoglobin ≥ 9.0 g/dL. Patients may be transfused to meet this criterion.
  • INR or aPTT ≤ 1.5 × upper limit of normal (ULN). This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
  • AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN, with the following exceptions: Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN. Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 × ULN.
  • Serum bilirubin ≤ 1.25 × ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled.
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance of ≥45ml/min (based on the Cockcroft Gault formula).
  • All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
  • For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate (< 1% per year) when used consistently and correctly, and to continue its use for 5 months after the last dose of Atezolizumab and/or 6 months after the last dose of Bevacizumab, whichever is later. Such methods include: combined (oestrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD): intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.
  • For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [< 1% per year] when used consistently and correctly, and to continue its use for 6 months after the last dose of Bevacizumab. Male patients should not donate sperm during this study and for at least 6 months after the last dose of Bevacizumab.
  • Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs. The same rules are valid for male patients involved in this clinical study if they have a partner of childbirth potential. Male patients must always use a condom.
  • Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Spain25 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

  • Hospital General de Alicante

    Alicante, Alicante, 03010

  • ICO Badalona

    Badalona, Barcelona, 08916

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

  • Consorcio Hospitalario Provincial de Castelló

    Castelló, Castelló, 12004

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Complejo Hospitalario de Jaén

    Jaén, Jaén, 23007

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

  • Hospital La Princesa

    Madrid, Madrid, 28006

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital General Universitario de Málaga

    Málaga, Málaga, 29010

  • Hospital Universitario Son Espases

    Palma de Mallorca, Mallorca, 07120

  • Hospital Universitario Son Llàtzer

    Palma de Mallorca, Mallorca, 07198

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08022

  • Complejo Hospitalario de Toledo

    Toledo, Toledo, 45004

  • Hospital Universitari i Politécnic La Fe

    Valencia, Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital General de Valencia

    Valencia, Valencia, 46014

  • Hospital Clínico Universitario de Valladolid

    Valladolid, Valladolid, 47003

  • Complexo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36036

Other trials in Spain

About this study

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 Patients.

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.

Read the detailed description

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.

Being tested
Atezolizumab-Bevacizumab
Keywords
NSCLC, Atezolizumab, Bevacizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab-BevacizumabDrug

    Also called Tecentriq-Avastin

    Atezoluzumab 1200 mg + Bevacizumab 15 mg / kg

Study groups in NCT03836066
Study groupRoleWhat they receive
Experimental: Atezolizumab plus Bevacizumab armExperimental1 group, Atezolizumab 1200mb + Bevacizumab 15 mg/kg (IV),every 21 days.
Receives: Drug: Atezolizumab-Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2019
  2. Study start15 May 2019
  3. Primary completion21 Oct 2024
  4. Study completion21 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03836066
Sponsor's protocol ID
GECP 18/03_TELMA
Other IDs
2018-004654-17, 2018
Acronym
TELMA
Status last verified
Nov 2025
First submitted
7 Feb 2019
Last updated
4 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36520426

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab-Bevacizumab in people with Non Small Cell Lung Cancer, run by Fundación GECP at 25 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Atezolizumab in Combination With Bevacizumab - PFS (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03836066, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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