RecruitingNCT04539977Updated May 9, 2023

PD-L1 Antibody (TQB2450) Plus Chemotherapy for Previously Untreated Limited- Stage Small-cell Lung Cancer

A Phase 2 interventional study of TQB2450 and TQB2450 in Small-cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 2, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
Started Sep 2020; still recruiting 6 years 1 month later.

Phase: Phase 2
Study type: Interventional
Enrollment: 40
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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 studied

Small-cell Lung Cancer

Browse trials for

Small Cell Lung Carcinoma 1,234

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 40 is below the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 157 studies on the registry; 94 are open to participants now.

Browse Shanghai Pulmonary Hospital, Shanghai, China studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

The patient shall sign the Informed Consent Form.
Aged 18 ≥ years.
Histological or cytological diagnosis of SCLC by needle biopsy, and extensive stage or limited stage (local advanced) confirmed by imageological examinations.
Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
Life expectancy is at least 12 weeks.
At least 1 measurable lesion according to RECIST 1.1.
Patients with good function of other main organs (liver, kidney, blood system, etc.):
- ANC count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L，hemoglobin ≥90 g/L;
- the international standard ratio of prothrombin time (INR) and prothrombin time (PT) \< 1.5 times of upper limit of normal (ULN);
- partial thromboplastin time (APTT) ≤1.5×ULN;
- total bilirubin ≤1.5×ULN;
- alanine aminotransferase (ALT) aspartate aminotransferase (AST) ≤2.5×ULN, or ALT and AST ≤5×ULN in the patients with liver metastatic tumor.
Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of TQB2450 (whichever is later).

Exclusion criteria

Exclusion Criteria:

Participants who have received any systemic anti-cancer treatment for SCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
Administration of any Chinese medicine against cancer before administration of the drug;
Participants with cancer other than SCLC (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study;
Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial;
Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted;
Participants who are allergic to the test drug or any auxiliary materials
Participants with active hepatitis B, hepatitis C or HIV;
The vaccine was administered within 4 weeks of the start of the trial;
Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial;
Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion;
The patients have active pia meningioma, uncontrolled or untreated brain metastases.
Pregnant or lactating women;
Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
Participated in another therapeutic clinical study
Other factors that researchers think it is not suitable for enrollment.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

Experimental
LS-SCLC Surgery
Induction therapy: TQB2450 1200mg, d1+carboplatin (AUC5) , d1+ etoposide 100mg/m2, d1,d2,d3, q3w, 4 cycles. Surgery (decided by MDT) Maintenance therapy: Etoposide,100 mg/m2 , d1-3 + Carboplatin,AUC5 (ivgtt, q3w,Two cycles) + TQB24501200mg, d1 (ivgtt, q3w, 1 Year) or progression disease, or other discontinuation criteria (intolerant toxicity, no more clinical benefit, receiving another anti-tumor regimen \[except radiotherapy\], withdrawal of informed consent or death).
Drug: TQB2450
Experimental
LS-SCLC Radiotherapy
Induction therapy: TQB2450 1200mg, d1+carboplatin (AUC5) , d1+ etoposide 100mg/m2, d1,d2,d3, q3w, 4 cycles. Radiotherapy (decided by MDT) Maintenance therapy: Etoposide,100 mg/m2 , d1-3+Carboplatin,AUC5 (ivgtt, q3w,Two cycles)+TQB24501200mg, d1(ivgtt, q3w, 1 Year) or progression disease, or other discontinuation criteria (intolerant toxicity, no more clinical benefit, receiving another anti-tumor regimen \[except radiotherapy\], withdrawal of informed consent or death).
Drug: TQB2450

Interventions

DrugTQB2450
Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year)
Also known as: Carboplatin, Etoposide
DrugTQB2450
Inductive therapy: TQB2450 + EC(4 cycles) Maintenance therapy: TQB2450+EC(2 cycles) followed byTQB2450 (1 year)
Also known as: Carboplatin, Etoposide

What researchers measure

Primary outcomes

Objective response rate (ORR)
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation after 3 weeks in all patients who have completed the inductive/neoadjuvant therapy. Only patients with measurable lesions at baseline will be analyzed.
Time frame: up to 16 months

Secondary outcomes

Event-free survival (EFS)
It refers to the time from the first administration of TQB2450 in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Time frame: up to 60 months
Progression-free survival (PFS)
It refers to the time from the first administration of TQB2450 in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
Time frame: up to 60 months
Disease-free survival (DFS)
It refers to the time from radical surgery to relapse or death of a participant due to disease progression. In the case of a patient who still survives at the time of analysis, the latest evaluation date will be used for interpolation (censoring).
Time frame: up to 60 months
Overall survival (OS)
It is defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
Time frame: up to 63 months
Major pathologic response (MPR)
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery.
Time frame: up to 5 months
Safety: frequency of severe adverse events
The frequency of severe adverse events from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
Time frame: up to 18 months
Health related quality of life (HRQol)
The assessment is made according to the Quality of Life Scale for Lung Cancer Patients (EORTC-QLQ-C30 \& LC13, Version 3). EORTC's QLQ-C30 \& LC13 (V3.0) is a core scale for lung cancer patients, with a total of 43 items. Among them, Item 29 and 30 are divided into seven grades, which are assigned with 1 to 7 scores according to the answer options. The other items are divided into 4 grades: Not at All, A Little, Quite a Bit, and Very Much, assigned with 1 to 4 scores respectively. The higher score, the worse quality.
Time frame: up to 12 months

Study locations

1 of 1 sites recruiting

Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality 200433, China
- Peng Zhang, MD · Contact · zhangpeng1121@outlook.com
Recruiting

References and documents

Individual participant data

Plan to share: Undecided — The researchers will consider whether IPD is available to other researchers only after the paper is published

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2020 (actual). Primary completion is estimated for Dec 2023, 39 months after the start.

Of 151 non-industry phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 75. This study's planned 39 months is below that.

Counting every sponsor, half of 200 studies reached it within 44 months; a quarter within 29 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 26, 2020
First posted: Sep 7, 2020
StartActual: Sep 1, 2020
Primary completionEst.: Dec 31, 2023
CompletionEst.: Dec 31, 2028
Last update: May 9, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04539977
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Responsible party: Peng Zhang (Director of science and education department, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted: Sep 7, 2020
Start date: Sep 1, 2020
Primary completion: Dec 31, 2023 (estimated)
Completion: Dec 31, 2028 (estimated)
Last update: May 9, 2023

Study contacts

Peng Zhang, MD

Contact

zhangpeng1121@outlook.com

+8613512185932

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Benmelstobart

Other studies in this condition

Small Cell Lung Carcinoma →

Other studies from this sponsor

Shanghai Pulmonary Hospital, Shanghai, China →

Start the discussion