Study which tests 2 medications (SB27, Keytruda) to compare how effective, safe and well tolerated in a large number of metastatic non-squamous non-small cell lung cancer patients.
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2024/02/062974
- Lead Sponsor
- Samsung Bioepis Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subjects who have a histologically confirmed or cytologically confirmed diagnosis of stage IV (M1a, M1b, or M1c of American Joint Committee on Cancer 8th edition) nonsquamous NSCLC.
2. Subjects who have at least one measurable lesion per RECIST v1.1 criteria on imaging modalities (computed tomography scan or magnetic resonance imaging scan) by the local site Investigator assessment.
3. Subjects who have a documented PD-L1 result by the US FDA-approved test (PDL1 IHC 22C3 pharmDx assay) within 12 weeks from the date of Randomisation.
a. If no prior PDL1 result is available at Screening, the subject must be assessed for PD-L1 result prior to the date of Randomisation using the stated method (PDL1 IHC 22C3 pharmDx assay) at a qualified local laboratory. For PD-L1 assessment, newly obtained (core or excisional) biopsy or archival tumour tissue sample (obtained within 12 weeks from the date of Randomisation) from locations not irradiated prior to biopsy is acceptable and formalin-fixed paraffin embedded (FFPE) tumour tissue sample blocks are preferred. Fine needle aspirates or biopsy, brushing, cell blocks, or tumour tissue from bone metastases that is subject to decalcification are not acceptable.
4. Subjects who have NOT received prior systemic therapy (including cytotoxic chemotherapy, targeted therapy, or antineoplastic biological therapy) for their metastatic NSCLC.
5. Male or female aged greater than equal to 18 years old at the time of signing the informed consent form (ICF), if local regulations are different in this regard, follow the local regulations.
6. ECOG performance status of 0 or 1.
7. Subjects who have a life expectancy of at least 3 months from Screening.
8. Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures.
9. Female subjects of nonchildbearing potential female (e.g., having congenital or acquired condition that prevents childbearing, having history of hysterectomy and-or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation or occlusion, or postmenopausal, OR childbearing potential who have a negative urine or serum pregnancy test within 3 days prior to receiving the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
10. Must agree to use adequate methods of contraception starting with the first dose of study treatment through 4 months after the last dose of IP administration and 6 months after the last dose of non-IPs administration.
11. Subjects must have adequate organ functions at Screening as indicated by the clinical laboratory values.
a. Haematological
i. Absolute neutrophil count (ANC) greater than equal to 1,500 per µL without granulocyte colonystimulating factor (G-CSF) support within 4 weeks prior to the date of
Randomisation.
ii. Platelet count greater than equal to 100,000 per µL without platelet transfusion within 4 weeks prior to the date of Randomisation.
iii. Haemoglobin greater than equal to 9.0 g per dL without erythropoietin dependency and transfusion within 4 weeks prior to the date of Randomisation.
b. Renal
i. Calculated creatinine clearance greater than equal to 50 mL per min.
c. Hepatic
i. Serum total bilirubin less than equal to 1.5 × upper limit of normal (ULN).
ii. Aspartate tra
1.Subjects who have documentation of presence of tumour activating epidermal growth factor receptor (EGFR) mutations OR presence of anaplastic lymphoma kinase (ALK) rearrangements OR presence of c-ros oncogene 1 (ROS1) rearrangements.
2.Subjects who are currently receiving or have received prior treatment with any of the following, including in the adjuvant neoadjuvant setting:
a.Any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent OR an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, LAG-3, TIGIT, OX40, and CD137, etc.).
3.Subjects who have received prior palliative radiotherapy within 2 weeks prior to the date of Randomisation or received lung radiation therapy of more than 30 Gray (Gy) within 6 months prior to the date of Randomisation. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
4.Subjects who have predominantly squamous cell histology NSCLC. Mixed tumours will be categorised by the predominant cell type; if small cell elements are present, the subject is ineligible.
5.Subjects who have a known severe hypersensitivity reaction to treatment with another monoclonal antibody or any component of platinum-containing compounds or pemetrexed.
6.Subjects who are unable or unwilling to take folic acid or vitamin B12 supplementation.
7.Subjects who are currently participating in any interventional clinical study or have participated in a study of an investigational drug within 30 days or 5 half-lives of the investigational drug being studied prior to the date of Randomisation, whichever is longer, or using an investigational device within 30 days prior to the date of Randomisation.
8.Subjects who are expected to require any other form of systemic or localised antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, or surgical resection).
9.Subjects who have a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.
10.Subjects who have a history of interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organising pneumonia).
11.Subjects who have a history of malignancy other than NSCLC except if the subjects have undergone potentially curative therapy with no evidence of that disease recurrence for 5 years prior to Screening.
12.Subjects who have known untreated central nervous system (CNS) metastases or known carcinomatous meningitis.
a.Subjects with untreated and asymptomatic brain metastases (i.e., no neurological symptoms, no requirements for corticosteroids, no surrounding oedema, and no lesion greater than equal to 1.0 cm) first detected at Screening may participate but will require regular scan of the brain as a site of disease.
b.Subjects with previously treated brain metastases may participate provided that they are clinically and neurologically stable, and have no evidence of new or enlarging brain metastases (as determined by 2 brain images, both of which are obtained after treatment of the brain metastases. One of the brain images should be a brain image obtained at Screening and the other should be a brain image obtained at least 4 weeks prior to Screening). In addition, they are off systemic steroids for at least 2 weeks prior to the date of Randomisation.
13.Subjects with an a
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to demonstrate the equivalence in efficacy of SB27 to Keytruda, in terms of objective response rate (ORR) at Week 24 in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC).Timepoint: ORR at 24 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of SB27 compared to Keytruda. <br/ ><br>- ORR at specific time points other than primary endpoint <br/ ><br>- Confirmed ORR at Week 24 <br/ ><br>- PFS <br/ ><br>- OS <br/ ><br>- DORTimepoint: • ORR at Week 18, Week 30, and EOT follow-up visit of the Main Study <br/ ><br>• Confirmed ORR at Week 24 based on BICR <br/ ><br>• PFS at 1 year <br/ ><br>• OS at 1 year <br/ ><br>• DOR at 1 year;To evaluate the immunogenicity of SB27 compared to KeytrudaTimepoint: At Cycle 1, 3, 6, 9, and EOT or ET follow-up visit of the Main Study;To evaluate the pharmacokinetics (PK) of SB27 compared to KeytrudaTimepoint: At Cycle 1, 3, 6, and 9;To evaluate the safety and tolerability of SB27 compared to KeytrudaTimepoint: Throughout the study