Verified

HLX10 or Atezolizumab + chemotherapy for Extensive-stage Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Extensive-stage Small Cell Lung CancerHLX10 + chemotherapy (carboplatin-etoposide) - Drug
Eligibility
18 - No maximum age
All Sexes
What conditions do you have?
Select

Study Summary

This is a randomized, open-label study of HLX10 plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: Arm A (HLX10): HLX10 + chemotherapy (carboplatin-etoposide) Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)

Eligible Conditions
  • Extensive-stage Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: approximately up to 24 months

Month 24
OS
Month 14
ORR
Month 24
Average Plasma Concentration (Cavg)
Maximum Plasma Concentration (Cmax)
Minimum Plasma Concentration (Cmin)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
PFS

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Atezolizumab + chemotherapy
1 of 2
HLX10 + chemotherapy
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: HLX10 + chemotherapy · No Placebo Group · Phase 3

HLX10 + chemotherapy
Drug
Experimental Group · 1 Intervention: HLX10 + chemotherapy (carboplatin-etoposide) · Intervention Types: Drug
Atezolizumab + chemotherapy
Drug
ActiveComparator Group · 1 Intervention: Atezolizumab + chemotherapy (carboplatin-etoposide) · Intervention Types: Drug

Trial Logistics

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Trial Timeline

Screening: ~3 weeks
Treatment: 12 Months
Reporting: 60 Months

Who is running the clinical trial?

Shanghai Henlius BiotechLead Sponsor
77 Previous Clinical Trials
14,496 Total Patients Enrolled

Eligibility Criteria

Age 18 - No maximum age · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically or cytologically diagnosed lung cancer.
Answer yes if you have not yet received treatment for extensive-stage small cell lung cancer OR if you were previously diagnosed with limited-stage small cell lung cancer, your last treatment was at least 6 months ago.
You are not suffering from any major organ dysfunction.
Answer yes if you do not have any other active malignancies and you have not had a history of malignancy within the last 5 years. You may also answer YES if you have been cured for basal cell carcinoma, squamous-cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical cancer in situ and breast cancer in situ.
Answer yes if you do not have known or active brain metastasis and/or carcinomatous meningitis
You have been newly diagnosed with extensive- stage small cell lung cancer
You have full mobility even with current symptoms
Answer yes if you do not have HIV, Hepatitis B or Hepatitis C

Who else is applying?

What state do they live in?
Washington100.0%
How old are they?
65+50.0%
18 - 6550.0%
What site did they apply to?
Research site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%