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A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer

A Phase II/III Study to Compare IBB0979 in Combination With Topotecan Versus Topotecan in Subjects With Relapsed Small Cell Lung Cancer

NCT07076095•SUNHO（China）BioPharmaceutical CO., Ltd.

View on ClinicalTrials.gov

Summary

This study was designed to compare the efficacy and safety of IBB0979 in combination with topotecan versus topotecan in subjects with relapsed small cell lung cancer (SCLC).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥18 and ≤75 years, male or female.
•2. Histologically confirmed SCLC.
•3. Relapsed small cell lung cancer (limited-stage, extensive-stage) that has failed or progressed after first-line or second-line systemic therapy.
•4. At least one measurable lesion according to RECIST version 1.1.
•5. ECOG PS 0 or 1.
•6. Life expectancy ≥ 3 months.
•7. Adequate organ function.
•8. Men or women should be using adequate contraceptive measures throughout the study. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
•9. Signed and dated Informed Consent Form.

Exclusion Criteria

•1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
•2. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
•3. History of anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration.
•4. History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
•5. History of major organ surgery (with exception of aspiration biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product administration, or selective operation is required during the trial.
•6. History of systemic corticosteroid therapy with exceptions defined in the protocol.
•7. Treatment with immunomodulatory agents, including but not limited to thymosin, interleukin-2 and interferon within 14 days prior to the initiation of investigational product administration.
•8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.
•9. History of prior allogeneic stem-cell or solid organ transplantation.
•10. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
+14 more criteria

Key Dates

Start Date

August 1, 2025

Primary Completion Date

August 1, 2028

Completion Date

August 1, 2031

Last Updated

July 21, 2025

Enrollment

200

ESTIMATED participants

Conditions

Small Cell Lung Cancer

Interventions

IBB0979

DRUG

topotecan hydrochloride for injection

DRUG

Contacts

ya ze jiao

CONTACT

15950520087 15950520087@163.com

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Non-small Cell Lung Cancer (NSCLC)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II/III Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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