A study to compare effects and safety of CT-P51 and Keytruda in patients with previously untreated metastatic lung cancer

Phase 3

Recruiting

Conditions: Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Registration Number: 2024-514048-98-00

Lead Sponsor: Celltrion Inc.

Brief Summary: The primary objective of this study is to demonstrate the therapeutic equivalence of CT-P51 and Keytruda in terms of ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the intent-to-treat(ITT) set.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruiting

Sex: Not specified

Target Recruitment: 210

Inclusion Criteria

Male or female ≥ 18 years

Stage IV, non squamous NSCLC

Patient with negative result in both EGFR mutation and ALK rearrangement. Patients already known to have ROS1 rearrangement, MET exon 14 skipping, RET rearrangement, or BRAF V600E mutation will be excluded if ROS1, MET, RET, or BRAF-directed therapy is indicated by local guidelines

Have a tumor sample not irradiated prior to biopsy that is adequate for PD-L1 assessment by immunohistochemistry (IHC) assay and obtained within 6 months prior to randomization

Have not received prior systemic anticancer therapy for metastatic nsNSCLC (Prior adjuvant/neoadjuvant NSCLC therapy is permitted if completed at least 12 months prior to the development of metastatic disease.)

Have at least 1 measurable lesion per RECIST version 1.1 (Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.) a) Tumor lesions: ≥ 10 mm in long axis by CT scan b) Malignant lymph nodes: ≥ 15 mm in short axis by CT scan

Have a ECOG Performance score of ≤ 1, Life expectancy of at least 3 months

Have adequate organ function

Exclusion Criteria

Have predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible

Have carcinomatous meningitis or active CNS metastases. (Note: Patients with previously treated brain metastases at least 2 weeks prior to the first study drug administration and without suspicion of further CNS progression may participate.)

Have clinically significant third-space fluid; for example, ascites or pleural effusion that cannot be controlled by drainage or other procedures prior to the first dose

Had prior treatment with one or more of followings: a) anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathway b) any systemic anticancer therapy for metastatic disease c) major surgery (<3 weeks prior to the first dose) d) palliative radiotherapy for non-CNS metastases (<1 week prior to the first dose) e) radiotherapy to the lung that is of > 30 Gy (<6 months prior to the first dose)

Have known history of malignancy other than NSCLC in the past 5 years except adequately treated basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix

Is expected to require chronic systemic steroids

Have an active infection requiring systemic therapy (<2 weeks prior to the first dose)

Have interstitial lung disease or a history of pneumonitis that required steroids

Unable or unwilling to take folic acid or vitamin B12 supplementation

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set		ORR (CR + PR) based on the confirmed BOR by the end of Cycle 11 according to RECIST version 1.1 in the ITT set

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (29): Pula General Hospital Ospedale Generale di Pola
🇭🇷
Pula - Pola, Croatia
Klinicki bolnicki centar Sestre milosrdnice
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Grad Zagreb, Croatia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
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Kaunas, Lithuania
Nacionalinis vezio institutas
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Vilnius, Lithuania
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
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Walbrzych, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
🇵🇱
Lublin, Poland
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie
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Olsztyn, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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Warsaw, Poland
dr hab.n.med. Sławomir Mandziuk Specjalistyczna Praktyka Lekarska
🇵🇱
Lublin, Poland
Szpital Specjalistyczny W Prabutach Sp. z o.o.
🇵🇱
Prabuty, Poland
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Pula General Hospital Ospedale Generale di Pola
🇭🇷Pula - Pola, Croatia
Dragan Trivanovic
Site contact
+38598335797
Dragan.Trivanovic@obpula.hr

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