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Compares treatment options for Limited Stage Small Cell Lung Cancer
Official title BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)
ClinicalTrials.gov ID: NCT06773910
What this study is testing
What is BMS-986489?
BMS-986489 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for limited stage small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants. The main goals of this study are to: Evaluate the efficacy of BMS-986489 vs durvalumab Evaluate the safety profile of BMS-986489
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A)
- Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1
- Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy
- Completed concurrent chemotherapy and radiotherapy for LS-SCLC without progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1...
You likely can't join if
- Small-cell cancer not pulmonary in origin
- Large cell neuroendocrine carcinoma
- ES-SCLC
- Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC
- History of severe hypersensitivity reaction to monoclonal antibodies
- Known hypersensitivity to any excipients of atigotatug, nivolumab, or durvalumab
See the full eligibility criteria
Who can join
- At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A)
- Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1
- Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy
- Completed concurrent chemotherapy and radiotherapy for LS-SCLC without progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (computed tomography [CT] scan chest/abdomen/pelvis; Appendix B) within...
- Chemotherapy should consist of a platinum and IV etoposide. Participants who received at least 3 cycles of chemotherapy will be eligible to participate.
- Radiotherapy should be administered per institutional guidelines
- Prophylactic cranial irradiation (PCI) may be delivered at the discretion of the Investigator and institutional guidelines. PCI, if applicable, must be conducted after the end of chemoradiotherapy and completed between...
- Adequate hematologic and organ function
- Willingness to abide by protocol defined contraceptive requirements for the duration of the study.
What rules you out
- Small-cell cancer not pulmonary in origin
- Large cell neuroendocrine carcinoma
- ES-SCLC
- Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC
- History of severe hypersensitivity reaction to monoclonal antibodies
- Known hypersensitivity to any excipients of atigotatug, nivolumab, or durvalumab
- Grade ≥2 peripheral neuropathy by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- Active, prior, or suspected autoimmune disease, including autoimmune neurologic disorders such as paraneoplastic syndrome involving the CNS, peripheral sensory/motor nerves, or neuromuscular junction. Exceptions to this...
- Type 1 diabetes mellitus
- Hypothyroidism requiring only hormone replacement
- Skin disorders not requiring systemic treatment
- Autoimmune conditions not expected to recur during the study
- Diseases or conditions requiring chronic systemic corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive therapy within 14 days of starting study treatment. Limited-course (\ 10 mg daily...
- History of solid organ or bone marrow transplantation
- History of Grade ≥2 pneumonitis (excepting resolved infective pneumonitis)
- Any of the following cardiac criteria, currently or within the last 3 months:
- Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block...
- Congestive heart failure (New York Heart Association [NYHA] \> Grade 2) or classified as Class 3 or 4 by the NYHA Functional Classification (Appendix D)
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden...
- Participants with a left ventricular ejection fraction \<55% or the lower limit of normal of the institutional standard
- Uncontrolled hypertension, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg despite optimal medical management
- Active coronary artery disease, including unstable or newly diagnosed angina
- Myocardial infarction
- History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)
- History or current diagnosis of myocarditis
- As judged by the Investigator, participants with serious or uncontrolled medical disorders
- Presence of other active invasive cancers. Participants with a previously treated malignancy will be eligible to participate if treatment of that malignancy was completed at least 2 years before date of screening and...
- Received sequential chemotherapy and radiotherapy as a definitive treatment for LS-SCLC
- Treatment with any of the following:
- Any systemic anticancer chemotherapy, small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study...
- Wide-field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study treatment or has not recovered from side...
- Prior systemic treatment for LS-SCLC, with the exception of chemoradiotherapy and PCI
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-programmed cell death ligand 2 (anti-PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug...
- Prior treatment with fuc-GM-1 vaccine or targeted agent or similar vaccine targeting ganglioside antigens
- Current treatment with immunosuppressive medications
- Live attenuated vaccine within 100 days before first dose of study treatment
- Major surgery (excluding placement of vascular access) within 4 weeks of date of screening
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: Participants with chronic Grade 2 toxicities who are asymptomatic or...
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol
The study team makes the final eligibility decision.
Where it's taking place
- Daphne, Alabama, United States
- Santa Barbara, California, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Orange City, Florida, United States
- Palm Bay, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Arlington Heights, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- Corbin, Kentucky, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Maple Grove, Minnesota, United States
- Columbia, Missouri, United States
- White Plains, New York, United States
- Wilson, North Carolina, United States
- Cincinnati, Ohio, United States
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daphne, Alabama, United States; Santa Barbara, California, United States; Fort Myers, Florida, United States; Miami, Florida, United States; Ocala, Florida, United States; Orange City, Florida, United States and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.