Health Condition 1: C00-D49- Neoplasms Health Condition 2: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs Health Condition 3: C34- Malignant neoplasm of bronchus andlung
Conditions
Interventions
Intervention1: Pembrolizumab-Intas (Test) INTP58: Dose Formulation: Concentrate for solution for infusion
Unit Dose Strength: 100 mg per 4 mL (25 mg per mL) in a single dose vial
Route of Admi
Sponsors
Intas Pharmaceuticals Limited,
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Must sign an ICF indicating that the participant understands the purpose of and procedures required for the study as described in Section 10.1.3 and in this protocol and is willing to participate in the study. 2) Participants of either gender (assigned at birth) with age of greater than or equal to 18 completed years (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the informed consent. 3) Participants must have documented histologically or cytologically confirmed diagnosis of squamous or non-squamous non-small cell lung cancer. Mixed tumours will be categorized by the predominant cell type (squamous or non-squamous). However, if small cell or neuroendocrine elements are present, the participant is ineligible. 4) Documented current presence of locally advanced (i.e. stage IIIB/IIIC not planned for curative intent treatment options including definitive chemoradiotherapy or surgery) or metastatic (stage IV) or recurrent disease (not planned for loco-regional treatment options) per American Joint Committee on Cancer Version 9 Cancer Staging System. 5) Confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy [documented absence of any sensitizing EGFR mutations (exon 19 deletion, exon 21 p.L858R point mutation, exon 21 p.L861Q mutation, exon 18 p.G719X mutation, and exon 20 p.S768I mutation), ALK rearrangement, or ROS-1 rearrangement]. Refer to Section 8.1.5. 6) Known PD-L1 status (TPS scoring) or availability of tumour tissue for PD-L1 test at local laboratory. Refer to Section 8.1.4. 7) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 8) The participant with adequate haematologic, liver and renal function at screening visit. a) ANC greater than or equal to 1,500 per cu.mm (without granulocyte colony-stimulating factor support within 2 weeks prior to the date of the test) b Platelet greater than or equal to 1,00,000 per cu.mm (without any platelet transfusion platelet concentrate within 2 weeks prior to the date of the test) c) Haemoglobin greater than or equal to 9g per dL. Criteria must be met without erythropoietin stimulating agent dependency and without packed red blood cell (pRBC) or whole blood transfusion within 2 weeks prior to the date of the test). Chronic erythropoietin therapy is permitted provided that no dose adjustments were made within 1 month prior to the date of the test. d) Estimated creatinine clearance of greater than or equal to 45 mL per min by using the Cockcroft-Gault formula Note: Exclusionary value of the renal function can be confirmed via repeat testing if deemed necessary. e) Total bilirubin less than or equal to 1.5 into ULN (isolated total bilirubin greater than 1.5 into ULN with direct bilirubin less than or equal to ULN is allowed for those participants with known Gilbert s syndrome; Gilbert s syndrome is suggested by direct bilirubin less than 30 percent) Note: Due to variability and instability, exclusionary value of bilirubin is to be confirmed via repeat testing to establish proper baseline levels. f) AST SGOT less than or equal to 2.5 into ULN (less than or equal to 5 into ULN for participants with liver metastasis) g) ALT SGPT less than or equal to 2.5 into ULN (less than or equal to 5 into ULN for participants with liver m
Exclusion criteria
Exclusion criteria: 1) Known clinically significant (greater than or equal to Grade 3) allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof (refer to the IB USPI SmPC local prescribing information for IMP and NIMP), or other allergies that, in the opinion of the investigator, contraindicates participation in the study. 2) Contraindications to the use of pembrolizumab, carboplatin, pemetrexed or paclitaxel per local prescribing information. 3) Participants will be excluded if they have any of the following: Any history of malignancy in the last 5 years prior to the first dose of study intervention, other than cancer under study, which is considered at high risk of recurrence requiring systemic therapy OR Any active malignancy (i.e., progressing or requiring treatment change) other than cancer under study in the last 2 years prior to the first dose of study intervention. The only allowed exceptions are malignancies treated within the last 2 years period that are considered cured: Non-muscle invasive bladder cancer Nonmelanoma skin cancer or lentigo maligna who underwent adequate treatment with no active disease at present. Non-invasive cervical cancer. Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localised breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. Adequately treated carcinoma in situ. Localised non-invasive primary disease under surveillance. Localised prostate cancer (Any T, N0M0): Very-low, low or intermediate risk group, treated (radical prostatectomy radiation therapy focal treatment; with or without ADT) or untreated and under either observation or active surveillance; OR High or very-high risk group who have completed the treatment with curative intent (including adjuvant ADT) more than 6 months prior to full study screening and considered to have a very low risk of recurrence. Other malignancy that is considered cured with minimal risk of recurrence with low potential risk for risk of metastasis or death (e.g., 5-year OS rate greater than 90 percent) in consultation with the sponsor s medical monitor. 4) Received any other investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer, or is currently enrolled in an interventional investigational study. 5) Participant has received prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biologic therapy) for the treatment of advanced recurrent metastatic disease. Participants who received prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy (other than excluded) or chemoradiation therapy for nonmetastatic NSCLC are eligible as long as the last administration of the prior regimen occurred at least 06 months before diagnosis of metastatic advanced recurrent NSCLC. 6) Participants who are currently receiving or have received prior treatment with any of the following, including in the adjuvant neoadjuvant or definitive chemoradiation or maintenance setting: 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, TIM- 3, CD137,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the non-inferiority of INTP58 compared with pembrolizumab-reference in terms of objective response rate (ORR), both administered in combination with platinumdoublet chemotherapy as the first line treatment in participants with metastatic nonsmall cell lung cancerTimepoint: Predose, 0.250 h, 0.500 h, 1.000 h, 2.000 h, 3.000 h, 6.000 h, 24.000 h, 48.000 h, 72.000 h, 120.000 h, 168.000 h, 264.000 h, 360.000 h and 504.000 h, Predose of (Cycle 3), (Cycle 4) (Cycle 5) (Cycle 6), (Cycle 7), (Cycle 8), End-of-treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterise the pharmacokinetic of INTP58 and pembrolizumab-reference after the first dose, all administered in combination with platinum-doublet chemotherapy To characterise trough blood levels during the treatment of INTP58 with pembrolizumab-reference, all administered in combination with platinum-doublet chemotherapy To evaluate the anti-tumour activity of INTP58 compared with pembrolizumabreference, both administered in combination with platinum-doublet chemotherapy To evaluate the safety of INTP58 with pembrolizumab-reference, both administered in combination with platinum-doublet chemotherapy To evaluate the immunogenicity of INTP58 with pembrolizumab-reference, both administered in combination with platinumdoublet chemotherapyTimepoint: Predose, 504.000 h, Predose of (Cycle 3), (Cycle 5), End-of-treatment visit | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed