Verified

HLX10 + carboplatin/cisplatin-etoposide + radiotherapy for Small Cell Lung Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Small Cell Lung Cancercarboplatin/cisplatin-etoposide - Drug
Eligibility
18 - No maximum age
All Sexes
What conditions do you have?
Select

Study Summary

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.

Eligible Conditions
  • Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: up to 36 months

up to 36 months
Overall survival(OS
up to approximately 24months
Progression-free survival

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

HLX10 + carboplatin/cisplatin-etoposide + radiotherapy
1 of 2
placebo + carboplatin/cisplatin-etoposide + radiotherapy
1 of 2

Experimental Treatment

Non-Treatment Group

482 Total Participants · 2 Treatment Groups

Primary Treatment: HLX10 + carboplatin/cisplatin-etoposide + radiotherapy · Has Placebo Group · Phase 3

HLX10 + carboplatin/cisplatin-etoposide + radiotherapyExperimental Group · 4 Interventions: carboplatin/cisplatin-etoposide, Thoracic radiotherapy, Prophylactic Cranial Irradiation (PCI), HLX10 · Intervention Types: Drug, Radiation, Radiation, Drug
placebo + carboplatin/cisplatin-etoposide + radiotherapyPlaceboComparator Group · 4 Interventions: Placebo, carboplatin/cisplatin-etoposide, Thoracic radiotherapy, Prophylactic Cranial Irradiation (PCI) · Intervention Types: Drug, Drug, Radiation, Radiation

Trial Logistics

Logistics

Travel, including flights, are covered

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

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

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
14,214 Total Patients Enrolled

Eligibility Criteria

Age 18 - No maximum age · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female, aged ≥18 years when signing the ICF.
You are not suffering from any major organ dysfunction.
You have been newly diagnosed with limited-stage small cell lung cancer
You are completely mobility even with current symptoms
Answer yes if you have not received treatment for limited-stage small cell lung cancer such as radiotherapy, chemotherapy, and immunotherapy.
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 HIV, Hepatitis B or Hepatitis C