Anti-PD-1 Antibody Therapies of Camrelizumab in Combination With Pemetrexed and Carboplatin as First-line Treatment in Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

NCT05841472 | Recruiting Phase 2

• 1 other identifier: CG-SHR-1210-2-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief Summary

The objective of this bridging study is to acquire new drug approval in Korea for camrelizumab (SHR-1210), a drug that has already been approved in China for treatment in patients with histologically or cytologically confirmed advanced or metastatic (Stage IIIB-IV), EGFR/ALK wild-type, non-squamous, non-small cell lung cancer. In this study, subjects with advanced or metastatic, EGFR/ALK wild-type, non-squamous, non-small lung cancer will receive anti-PD-1 antibody therapy of camrelizumab in combination with pemetrexed + carboplatin as first-line treatment for at least 8 cycles (24 weeks). Then, the best overall RECIST responses (BOR) from subjects who have had at least 1 post-baseline tumor assessment will be evaluated to confirm that camrelizumab, a drug that has already been approved China, has similar efficacy in the Korean population as in the Chinese population.

Conditions

Non Squamous Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Best overall RECIST response, BoR

  up to 8 cycles (24 weeks) of the last subject

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  6 months, 12 months, 24 months

• Objective response rate (ORR)

  6 months, 12 months, 24 months

• Overall survival (OS)

  up to 6 months from the last visit of the last patient

• Disease control rate (DCR)

  6 months, 12 months, 24 months

Study Arms (1)

Camrelizumab, Pemetrexed and Carboplatin

EXPERIMENTAL

Drug: Camrelizumab (SHR-1210), Pemetrexed, and Carboplatin

Interventions

Camrelizumab (SHR-1210), Pemetrexed, and Carboplatin DRUG

* 200 mg of Camrelizumab (SHR-1210) is administered intravenously over a period of around 20-60 min on Day 1 of each 3-week cycle. * Pemetrexed 500 mg/m2 is administered intravenously on Day 1 of each 3-week cycle, over a period of more than 10 minutes * Carboplatin of AUC 5 is administered intravenously on Day 1 of each 3-week cycle (hydrated as appropriate), over a period of more than 30 minutes by 4-6 cycles.

Camrelizumab, Pemetrexed and Carboplatin

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged between 19-80 at the time of signing the informed consent form, male or female.
• Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC), Stage IIIB-IV (as per the International Association for the Study of Lung Cancer (IASLC) Staging Handbook in Thoracic Oncology, 8th Edition).
• The site must provide documented information on EGFR mutation and ALK translocation and both must be negative. Subject cannot be randomized before receiving the source document for EGFR mutation and ALK translocation.
• A tumor tissue specimen collected upon or after diagnosis of advanced or metastatic disease, either fresh or archival (within 6 months prior to the first dose), must be provided. At least 10 unstained slides can be generated from the formalin fixed, paraffin-embedded (FFPE) tumor tissue block for immunohistochemistry assay or biomarker testing (or may be less than 10 slides as approved by the sponsor's medical monitor). Specimen obtained from fine needle aspiration, pleural fluid smear, or drill biopsy are unacceptable. For bone lesions, specimen without soft tissue components or decalcified bone tumor specimen is also unacceptable.
• Subjects who have not previously received systemic chemotherapy for advanced/metastatic NSCLC. Chemotherapy as neo-adjuvant/adjuvant therapy or chemoradiotherapy is permitted, as long as the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease.
• Radiographically measurable lesions via CT or MRI, as per RECIST 1.1. The tumor assessment of baseline should be performed within 28 days prior to the first dose.
• ECOG PS score: 0-1.
• Expected survival ≥ 3 months.
• Subjects must undergo all screening laboratory tests as per the protocol within 14 days prior to the first dose. Laboratory tests at screening must meet the following criteria:
• \) Hematology: (without blood transfusion, G-CSF, or medication within 14 days prior to screening)
• Hemoglobin (HB) ≥ 90 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
• Platelet (PLT) ≥ 100 x 109/L;
• White blood cell (WBC) ≥ 4.0 x 109/L and ≤ 15 x 109/L; 2) Biochemistry: (no blood or albumin transfusion within 14 days prior to screening)
• AST and ALT ≤ 1.5 x ULN (≤ 5 x ULN for liver metastasis);

You may not qualify if:

• Subjects with other histological types besides non-squamous non-small cell lung cancer, including mixed carcinomas or NSCLC with small cell lung cancer components/neuroendocrine differentiation.
• Subjects with EGFR mutation or ALK translocation.
• Subjects without radiographically measurable lesions.
• Subjects with carcinomatous meningitis and spinal cord compression.
• Subjects with untreated central nervous system (CNS) metastasis. Subjects with previously treated CNS metastases may participate if the CNS metastasis is limited to the supraentorial and cerebellar regions, adequately treated, and clinically stable (by radiological tumor assessments, preferably enhanced MRI or CT) for at least 4 weeks, and if the subject's neurological symptoms can return to NCI-CTCAE Grade ≤ 1 within 2 weeks prior to the first dose. In addition, subjects who are using corticosteroids for clinical symptoms are not eligible, unless the doses of corticosteroids stable or gradually reduced to prednisone ≤ 10 mg/day (or equivalent) -for at least 2 weeks.
• Subjects who can be treated with surgical resection or radical radiotherapy.
• Subjects who previously received treatment with any other anti-PD-1(L1) or CTLA4 monoclonal antibodies.
• \. Medical history and complications
• Subjects with any active, known, or suspected autoimmune diseases. Subjects who are clinically stable and do not require systemic immunosuppressants, such as those with Type I diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases that do not require systemic treatment (for example, vitiligo, psoriasis or alopecia), or subjects in whom recurrence are not expected without external triggers may be eligible.
• Subjects with any complication that require systemic corticosteroids like prednisone (\> 10 mg/day or equivalent) or other immunosuppressants within 14 days prior to the first dose. In the absence of active autoimmune disease, inhaled or topical use of corticosteroids, and physiologic hormone replacement therapy for adrenal insufficiencylike prednisone \> 10 mg/day or equivalent are permitted;
• Subjects who received cancer vaccines or other immunostimulatory anti-cancer agents (interferon, interleukin, thymosin, or immune cell therapy) within 1 month prior to the first dose.
• Subjects who are currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks (or 5 half-lives of the previous investigational agent) prior to the first dose.
• Subjects who are expected to require any other forms of anti-cancer treatment (including maintenance treatment with other drugs, radiotherapy, and/or surgical resection) for NSCLC while on study.
• Subjects who received major surgery within 4 weeks prior to the first dose, non-thoracic radiation therapy \> 30 Gy within 4 weeks prior to the first dose, thoracic radiation therapy \> 30 Gy within 24 weeks prior to the first dose, or palliative radiation ≤ 30 Gy within 2 weeks prior to the first dose, and failed to recover from the toxicities and/or complications of these interventions to NCI-CTC AE Grade ≤ 1 (except for alopecia and fatigue). Palliative radiotherapy for symptomatic control is permitted, but must be completed within 2 weeks prior to the first dose and no additional radiotherapy should be scheduled for the same lesion.
• Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe lung diseases that seriously affect pulmonary function.

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (8)

Korea University Anam Hospital

Anam, South Korea

RECRUITING

Hallym University Sacred Heart Hospital

Anyang, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, South Korea

RECRUITING

Catholic University of Korea EunPyeong St. Mary's Hospital

Seoul, South Korea

RECRUITING

Catholic University of Korea Yeouido St. Mary's Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Seoul Asan Hospital

Seoul, South Korea

RECRUITING

Busan National University Hospital Yangsan

Yangsan, South Korea

RECRUITING

MeSH Terms

Interventions

camrelizumab; Pemetrexed; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Sung Yong Lee, MD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Hye Kim

CONTACT

+821087370206; khkim@cgxinc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 3, 2023
• Study Start: August 23, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

KR (8)