Actively Recruiting
PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2023-05-09
40
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a non-randomized, open-label, single-center, phase II trial to evaluate the safety and effectiveness of surgery or radiotherapy after PD-L1 inhibitor (TQB2450) and chemotherapy induction therapy followed by maintenance therapy as first-line treatment in patients limited-stage SCLC.
CONDITIONS
Official Title
PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Aged 18 years or older
- Diagnosed with small-cell lung cancer (limited or extensive stage) confirmed by biopsy and imaging
- ECOG performance status score of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable tumor lesion according to RECIST 1.1
- Adequate liver, kidney, and blood function based on specific laboratory values
- Fertile female patients agree to use effective contraception for at least 120 days after chemotherapy or last dose of TQB2450 and have negative pregnancy test within 7 days prior to enrollment
- Unsterilized male patients agree to use effective contraception during the study and for at least 120 days after chemotherapy or last dose of TQB2450
You will not qualify if you...
- Previous systemic anti-cancer treatment for small-cell lung cancer
- Prior use of Chinese medicine against cancer before study drug administration
- Cancer other than small-cell lung cancer within 5 years except certain cured or in situ cancers
- Unstable systemic diseases such as active infections or uncontrolled heart conditions
- Active or suspected autoimmune diseases requiring systemic treatment
- Use of antibiotics for infection within 4 weeks before the trial
- Systemic corticosteroid or immunosuppressive treatment within 2 weeks before first dose (with some exceptions)
- Allergies to the study drug or its components
- Active hepatitis B, hepatitis C, or HIV infection
- Vaccination within 4 weeks before the trial
- Major surgery or severe trauma within 2 months before the trial
- Uncontrolled pleural, pericardial effusion, or ascites requiring drainage within 2 weeks before enrollment
- Active brain metastases or untreated central nervous system tumors
- Pregnant or lactating women
- Nervous system or mental disorders preventing cooperation
- Participation in another therapeutic clinical study
- Other reasons deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
P
Peng Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here