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Carcinoma, Small Cell LungPhase 2NCT04308785

A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer

A Phase 2 study testing Atezolizumab and Tiragolumab in people with Carcinoma, Small Cell Lung, run by Hoffmann-La Roche at 17 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Small Cell Lung
What is being tested?
Atezolizumab and Tiragolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
17 sitesChina
Study dates
1 Dec 2021to 25 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Signed Informed Consent Form
  • ECOG performance status of 0 or 1
  • Histologically confirmed limited-stage SCLC.
  • Patients who have not progressed during/after chemoradiotherapy.
  • Concurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.
  • Adequate hematologic and end organ function.
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  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.
  • For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.
  • Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.
  • Patients must submit a pre-treatment tumor tissue sample.

Who cannot join

  • Histology mixtured or Extensive-stage SCLC (per the Veterans Administration Lung Study Group (VALG) staging system).
  • Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
  • Malignancies other than SCLC within 5 years prior to study treatment initiation, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and 90 days after the final dose of tiragolumab, and 6 months for chemotherapy after the final dose of the chemotherapy treatment.
  • Active or history of autoimmune disease or immune deficiency
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  • Uncontrolled or symptomatic hypercalcemia
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Positive test result for HIV
  • Patients with active hepatitis B or hepatitis C virus
  • Active tuberculosis
  • Severe infections within 4 weeks prior to study treatment initiation, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Significant cardiovascular disease
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA4, anti-tigit, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Unresolved toxic effects of grade 2 or higher (CTCAE 5.0), including grade ≥ 2 pneumonitis from previous therapy
  • Active EBV infection or known or suspected chronic active EBV infection at screening.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Jilin Cancer Hospital

    Changchun, 132013

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • Southwest Hospital , Third Military Medical University

    Chongqing, 400038

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510663

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Anhui Province Cancer Hospital

    Hefei, 230031

  • Shandong Cancer Hospital

    Jinan, 250117

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • Fudan University Shanghai Cancer Center; Medical Oncology

    Shanghai, 201315

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Tumor Center,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430023

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

About this study

Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 2 Study to Investigate the Efficacy and Safety of Atezolizumab With or Without Tiragolumab as Consolidation Therapy in Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed After Chemoradiotherapy

This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.

Read the detailed description

Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.

Being tested
Atezolizumab, Tiragolumab, Placebo
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered at a dose of 1200 mg intravenously on the first day of each 21-day cycle.

  • TiragolumabDrug

    Tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each 21-day cycle.

  • PlaceboOther

    Placebo matching to tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each cycle.

Study groups in NCT04308785
Study groupRoleWhat they receive
Arm A: Atezolizumab + TiragolumabExperimentalParticipants will receive atezolizumab + tiragolumab intravenously on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and tiragolumab treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Receives: Drug: Atezolizumab; Drug: Tiragolumab
Arm B: Atezolizumab + PlaceboExperimentalParticipants will receive atezolizumab + placebo on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and placebo treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).
Receives: Drug: Atezolizumab; Other: Placebo

What is being measured

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

  1. Investigator Assessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population

    PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.

    Measured: Randomization up to approximately 48 months

Secondary outcomes (18)

  1. Overall Survival (OS) in the ITT Population

    OS is defined as the time from randomization to death from any cause or last follow-up.

    Measured: Randomization up to approximately 48 months

  2. PFS Rate at 1 Year and 2 Years in the ITT Ppulation

    PFS rate at 1 year and 2 years, defined as the proportion of patients remaining stable disease or ongoing response per RECIST v1.1 at 1 year and 2 years from the time of randomization.

    Measured: Baseline to 1 Year and 2 Years

  3. OS Rate at 1 Year, 2 Years and 3 Years in the ITT Population

    OS rate at 1 year, 2 years and 3 years is defined as the proportion of patients remaining alive 1 year, 2 years and 3 years from the time of randomization.

    Measured: Baseline to 1 Year, 2 Years and 3 Years

  4. Objective Response Rate (ORR) in the ITT Population

    ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1 in patients who have measurable disease at baseline.

    Measured: Randomization up to approximately 48 months

  5. Duration of Response (DOR) in the ITT Population

    DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator according to the RECIST v1.1 or death from any cause, whichever occurs first, in the patients who have experienced a CR or PR (unconfirmed) during the study.

    Measured: Time from first documentation of complete response (CR) or partial response (PR) up to approximately 48 months

  6. Investigator Accessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population by Response to Chemoradiotherapy (CRT) [Stable Disease (SD) vs. Complete Response (CR)/Partial Response (PR)]

    PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.

    Measured: Randomization up to approximately 33 months

  7. Overall Survival (OS) in the ITT Population by Response to CRT (SD vs. CR/PR)

    OS is defined as the time from randomization to death from any cause or last follow-up.

    Measured: Randomization up to approximately 48 months

  8. Objective Response Rate (ORR) in the ITT Population by Response to CRT (SD vs. CR/PR)

    ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1.

    Measured: Randomization up to approximately 48 months

  9. Investigator Accessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population by Radiotherapy Timing (Concurrent vs. Sequential)

    PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.

    Measured: Randomization up to approximately 48 months

  10. Overall Survival (OS) in the ITT Population by Radiotherapy Timing (Concurrent vs. Sequential)

    OS is defined as the time from randomization to death from any cause or last follow-up.

    Measured: Randomization up to approximately 48 months

  11. Objective Response Rate (ORR) in the ITT Population by Radiotherapy Timing (Concurrent vs. Sequential)

    ORR is defined as the percentage of patients who attain complete response (CR) or partial response (PR) according to RECIST v1.1.

    Measured: Randomization up to approximately 48 months

  12. Percentage of Participants With All Adverse Events Related to Atezolizumab and Atezolizumab + Tiragolumab Treatment in the ITT Population

    Measured: Baseline up to approximately 48 months

  13. Percentage of Participants With Serious and Non-Serious Immune Mediated Adverse Events Related to Atezolizumab and Atezolizumab + Tiragolumab Treatment in the ITT Population

    Measured: Baseline up to approximately 48 months

  14. Percentage of Participants With All Adverse Events Related to Treatment in the ITT Population

    Measured: Baseline up to approximately 48 months

  15. Time to Deterioration (TTD) in Patient-Rported Lung Cancer Symptoms

    TTD is defined as the time from randomization to a patient's first ≥10-point score change from baseline in a scale maintained for at least two consecutive PRO assessments, or followed by death within 3 weeks of the first ≥10-point score change.

    Measured: Randomization up to approximately 48 months

  16. EORTC QLQ-C30 Score

    EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 Questionnaire, is a validated, reliable self-report measure. It consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales.

    Measured: Day 1 of first 3 cycles (each cycle is 21 days) then with tumor assessments & 3 months after radiographic disease progression or for patients who continue atezolizumab after radiographic disease progression loss of clinical benefit up to approx 48 months

  17. EORTC QLQ-LC13 Score

    The EORTC, European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire, QLQ-LC13 is a modular supplement to the EORTC quality-of-life questionnaire for use in lung cancer. This module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.

    Measured: Day 1 of first 3 cycles (cycle length=21 days), then with tumor assessments & 3 months after radiographic disease progression or for patients who continue atezolizumab after radiographic disease progression loss of clinical benefit up to approx 48 months

  18. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Based and Visual Analogue Scale (VAS) Scores

    The EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L), is a validated self-report health status questionnaire that is used to calculate a health status utility score for use in health economic analyses. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, as well as a visual analogue scale (VAS) that measures health state. Published weighting systems allow for creation of a single composite score of the patient's health status.

    Measured: Day 1 of first 3 cycles (each cycle is 21 days) then with tumor assessments & 3 months after radiographic disease progression or for patients who continue atezolizumab after radiographic disease progression loss of clinical benefit up to approx 48 months

Timeline

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

  1. First posted16 Mar 2020
  2. Study start1 Dec 2021
  3. Primary completion25 Jul 2023
  4. Study completion25 Jul 2023

Why it stopped: The sponsor's decision was based on the negative results of SKYSCRAPER-02.

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04308785
Sponsor's protocol ID
ML41257
Status last verified
Oct 2023
First submitted
12 Mar 2020
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab and Tiragolumab in people with Carcinoma, Small Cell Lung, run by Hoffmann-La Roche at 17 sites in China.

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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. 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?

The study was stopped early (reason given: The sponsor's decision was based on the negative results of SKYSCRAPER-02.). Results are not available in the source record.

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?

Investigator Assessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population (time frame: Randomization up to approximately 48 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 NCT04308785.

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 23 Oct 2023.

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