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Trial Title:
Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC
NCT ID:
NCT06477523
Condition:
SCLC, Extensive Stage
Conditions: Official terms:
Carboplatin
Etoposide
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
Description:
IV infusion
Arm group label:
LDRT+AK104+chemotherapy
Other name:
Cadonilimab
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and
3 of each 21-day cycle during the induction phase (Cycles 1-4).
Arm group label:
LDRT+AK104+chemotherapy
Other name:
Chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was
administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
Arm group label:
LDRT+AK104+chemotherapy
Other name:
Chemotherapy
Intervention type:
Radiation
Intervention name:
low-dose radiotherapy
Description:
The subjects will receive LDRT, from C1D1-C1D5, once a day for 3Gy, until the target dose
of 15Gy is achieved (Cycles 1).
LDRT treatment for primary/mediastinal positive lymph nodes/metastatic lesions during
maintenance therapy (C1D1-C1D5, 15Gy).
Arm group label:
LDRT+AK104+chemotherapy
Other name:
LDRT
Summary:
Phase Ib/II, open-label, multicentre study to evaluate the efficacy and safety of
low-dose radiotherapy (LDRT) combined with AK104 and chemotherapy as first-line treatment
for patients with ES-SCLC.
Detailed description:
This trial aims to assess the safety and efficacy of a new therapeutic strategy that
combines to low-dose radiotherapy combination With AK104 plus etoposide and
carboplatin/cisplatin.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 to 80 years old.
- Be able and willing to provide written informed consent and to comply with all
requirements of study participation (including all study procedures).
- Histologically or cytologically confirmed diagnosis of ES-SCLC per the Veterans
Administration Lung Study Group (VALG) staging system.
- No prior treatment for ES-SCLC.
- Measurable disease, as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status ≤ 1.
- Life expectancy ≥ 3 months.
- Adequate hematologic and end-organ function.
- All female and male subjects of reproductive potential must agree to use an
effective method of contraception, as determined by the Investigator, during and for
120 days after the last dose of study treatment.
Exclusion Criteria:
- Symptomatic or actively progressing Central nervous system metastases.
- Uncontrolled carcinomatous meningitis.
- Uncontrolled severe cancer pain
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent
drainage procedures (once a month or more frequently).
- Uncontrolled or symptomatic hypercalcemia.
- History of autoimmune disease.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (such as
bronchiolitis obliterans), drug-induced pneumonia, or idiopathic pneumonia, or
evidence of active pneumonia on chest computed tomography (CT) during screening.
- Active Tuberculosis infection.
- Significant cardiovascular disease.
- Major surgical procedure within 28 days prior to enrollment or anticipation of need
for major surgical procedure during the course of the study.
- Known additional malignancy that is progressing or requires active treatment.
- Active infection requiring systemic therapy
- Prior allogenic bone marrow transplantation or solid organ transplant.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the participant at high risk for treatment
complications.
- Receipt of live attenuated vaccination within 4 weeks prior to the first dose of
study treatment, or plan to receive live attenuated vaccine during the study.
- Currently receiving the treatment of hepatitis B virus infection..
- Received approved or under development systematic anti-tumor therapy within 28 days
before enrollment
- Previously received immune checkpoint agonists (antibodies to CD137 targets) or
immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies,
anti-CTLA-4 antibodies, etc.) , immune cell therapy and other treatment of any
immune mechanism for tumors
- Treatment with systemic immunosuppressive medications within 1 week prior to
enrollment..
- Known allergies or intolerant to test drugs or their excipients; or a known history
of severe hypersensitivity reactions to other antibodies.
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding.
- Received chest radiation therapy prior to the first dose.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
China West Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
You Lu, MD
Phone:
00862885423571
Email:
radyoulu@hotmail.com
Contact backup:
Last name:
Zhuoran Yao, MD
Phone:
13261660839
Email:
yaozhuoran@outlook.com
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
You Lu, MD.
Phone:
18980601763
Phone ext:
+86
Email:
radyoulu@hotmali.com
Contact backup:
Last name:
YiJun Wu, MD.
Phone:
17888841669
Phone ext:
+86
Email:
wuyj01029@163.com
Investigator:
Last name:
You Lu, MD.
Email:
Principal Investigator
Start date:
May 16, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06477523
