Health TrialsbyHealthPanel

A Study on the Efficacy of Atezolizumab Combined with Chemotherapy

ConditionLung Cancer, Small Cell
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

This is a multicenter phase III simulated RCT study aimed to compare the efficacy and safety of atezolizumab combined with chemotherapy versus placebo combined with chemotherapy in small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed Informed Consent Form

Male or female, 18 years of age or older

ECOG performance status of 0 or 1

Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system

Disqualifiers

Active or untreated CNS metastases as determined by computed tomography (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 ≥ 1 week prior to randomization

Leptomeningeal disease

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.

Trial population

This is a multi-center study to compare the efficacy and safety of atezolizumab plus chemotherapy versus placebo plus chemotherapy in small cell lung cancer.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Atezolizumab

    Drug

    Atezolizumab, 1200 mg intravenous infusion, 21 days per cycle

  • Etoposide

    Drug

    Etoposide,intravenous infusion, 100mg/m,21 days per cycle

  • Carboplatin

    Drug

    carboplatin,intravenous infusion, AUC=5, 21 days per cycle.

Treatment groups

1,430 Participants
are divided into 2 treatment groups
Group A: atezolizumab combined with chemotherapy3 interventions
Group B: chemotherapy2 interventions

Trial outcomes

Primary outcomes

1

progression free survival

Progression-free survival (PFS): refers to the time from the date of initiation of combination therapy to any objectively documented tumor progression or patient death (the last follow-up time for patients lost to follow-up; Patients who are still alive at the end of the study will be the end of follow-up at the end of the study).

Time frame
12 months

Secondary outcomes

1

objective response rate

Objective response rate (ORR): refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including complete response (CR) and partial response (PR) cases.

Time frame
12 months
2

duration of response

Duration of response (DOR): refers to the duration of a patient's time from the first documented confirmed response (CR or PR) to the first documentation of disease progression (PD) or death due to any cause, whichever occurs first.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Pulmonary Hospital, Shanghai, China

Lead sponsor

Source ClinicalTrials.gov
Apply now