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New treatment option for Small Cell Lung Cancer
Official title A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy
ClinicalTrials.gov ID: NCT07010263
What this study is testing
What is AK112?
AK112 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer.
Also referred to as Ivonescimab.
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 a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- The people voluntarily participated in the study with full informed consent and signed written informed consent form.
- Aged ≥18 years on day fo signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months
- Histologically or cytologically confirmed small cell lung cancer.
You likely can't join if
- Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components.
- Toxicities from previous anti-tumor treatments have not resolved to grade 0 or 1 based on the National Cancer Institute Common Terminology Criteria...
- Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia.
- Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage.
- History of active malignant tumors within the previous 5 years.
- Received major surgery within 28 days prior to the first dose of study drug, or expected to undergo major surgery during the study period within 28...
See the full eligibility criteria
- The people voluntarily participated in the study with full informed consent and signed written informed consent form.
- Aged ≥18 years on day fo signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months
- Histologically or cytologically confirmed small cell lung cancer.
- Documented limited-stage SCLC (Stage I-III SCLC [T any, N any, M0] according to the American Joint Committee on Cancer Staging Manual [AJCC Cancer Staging Manual, 8th Edition] or the Veterans Administration Lung Study...
- Have Received concurrent chemoradiotherapy regimen as defined in protocol and have not progressed following concurrent chemoradiotherapy.
- Adequate organ function.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days...
- Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components.
- Toxicities from previous anti-tumor treatments have not resolved to grade 0 or 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or to the levels specified in...
- Symptoms or signs of primary disease deterioration that the investigator judges clinically unacceptable, such as cachexia.
- Presence of pleural effusion, pericardial effusion, or ascites, which was clinically symptomatic or requiring frequent drainage.
- History of active malignant tumors within the previous 5 years.
- Received major surgery within 28 days prior to the first dose of study drug, or expected to undergo major surgery during the study period within 28 days after the first dose of study drug.
- Uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis, and other related diseases..
- Have serious neurological or mental illnesses, including dementia and epileptic seizures.
- Pregnant or lactating women.
- Have cardiovascular or cerebrovascular diseases or risk factors.
- Prior treatments with systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration of the study drugs. Prior treatment with Chinese...
- Prior treatments targeting immune mechanisms, including, but not limited to, immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy.
- Prior treatments with anti-angiogenic therapy.
- people requiring systemic treatment with corticosteroids (\>10mg/day prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.
- Known history of severe hypersensitivity reactions to other monoclonal antibodies or with a known history of allergy or hypersensitivity reactions to any of study drugs or their components.
- Active autoimmune diseases that require systemic treatment within 2 years prior to the study, or autoimmune diseases that the investigator judges to be potentially recurrent or require planned treatment.
- Known interstitial lung disease or non infectious pneumonia, which currently has symptoms or requires systemic corticosteroid treatment in the past,or investigator juges may affect the toxicity assessment or management...
- Known severe infection within 4 weeks prior to the first dose of study drug. Known active tuberculosis. Known active syphilis infection. Known history of immunodeficiency or positive HIV test results.
- .Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Active hepatitis B or active hepatitis C.
- Received a live vaccine within 30 days prior to the first dose of study drug, or planning to receive a live vaccine during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Beijin, Beijin, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Longyan, Fujian, China
- Zhangzhou, Fujian, China
- Lanzhou, Gansu, China
- Jiangmen, Guangdong, China
- Liuzhou, Guangxi, China
- Nanning, Guangxi, China
- Guangzhou, Guangzhou, China
- Guiyang, Guizhou, China
- Zunyi, Guizhou, China
- Shijiazhuang, Hebei, China
- Tangshan, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Xinxiang, Henan, China
- Zhengzhou, Henan, China
- Jingzhou, Hubei, China
+ 22 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Beijing, Beijing Municipality, China; Beijin, Beijin, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Longyan, Fujian, China; Zhangzhou, Fujian, China and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.