PDR001 in Patients With Non-small Cell Lung Cancer Harboring KRAS/NRAS Mutation or no Actionable Genetic Abnormalities

NCT03693326 | Unknown Phase 2

• 1 other identifier: STARTER_PDR001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase II, single-arm, open label study. All participating patients must sign on the written informed consent form, and a separate form of consent will be used for the use of tissue for the biomarker research.

Conditions

Cancer; Lung Cancer Metastatic; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  ORR is a proportion of patients with a best overall response defined as complete response or partial response by RECIST1.1

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months]

Secondary Outcomes (4)

• Duration of response

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months]

• Progression-free survival

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

• Overall survival

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

• Disease control rate

  At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months

Study Arms (1)

PDR001

EXPERIMENTAL

PDR001 300 mg (fixed dose) intraveneously every 3 weeks

Drug: PDR001

Interventions

PDR001 DRUG

PDR001 300 mg (fixed dose) intraveneously every 3 weeks

PDR001

Eligibility Criteria

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

You may qualify if:

• Subjects with histologically or cytologically confirmed, stage IV or recurrent NSCLC that carries a KRAS/NRAS mutation or no actionable mutation, which are identified by NGS.
• Squamous cell carcinoma and non-squamous cell carcinoma will be enrolled with 1:1 ratio for efficacy analysis according to histology
• Subjects who did not treated with prior anti-PD-1 antibody nor anti-PD-L1 antibodies
• ECOG performance status of 0 to 2
• Male or female; ≥ 18 years of age
• Patients those who showed disease progression after one or two prior platinum-containing regimen
• Patients who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for locally advanced disease are eligible, provided that progression has occurred ≥ 12 months from last therapy.
• Subjects with at least one measurable lesion (using RECIST 1.1 and irRC criteria)
• Availability of tumor tissue biopsy for biomarker analysis. Archival tissue can be used. Fine-needle aspirates will not be acceptable.
• Subjects who meet the following criteria:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥100 x 10\^9/L
• Serum creatinine ≥ 1.5 x upper limit of normal (ULN)
• AST (SGOT) and ALT (SGPT) ≥ 3 x upper limit of normal (ULN) (If there is Liver Metastasis ≥ 5 x upper limit of normal (ULN))
• Total bilirubin≥1.5 x upper limit of normal (ULN)

You may not qualify if:

• Patients who harboring EGFR mutation(s) and/or anaplastic lymphoma kinase (ALK) rearrangement will not be eligible for this trial.
• Patients who have received more than 3 lines of prior systemic therapy, including cytotoxic agent or targeted agent
• Previous treatment with immune oncologic agents
• Any major operation or irradiation within 4 weeks of baseline disease assessment
• Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
• Subjects with history of leptomeningeal metastasis
• Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma or cervical cancer in situ. Any cured cancer that is considered to have no impact in PFS and OS for the current NSCLC such as thyroid cancer.
• Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome (Corrected QT (QTcF) \>470 ms using Fridericia's correction on the screening ECG), 2° or more AV Block and uncontrolled hypertension)
• Pregnant or lactating female
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
• History of severe hypersensitivity reactions to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.
• Active, known or suspected autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease (Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll).
• Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
• Patient has peripheral neuropathy greater than grade 2
• Active HBV or HCV infection, HBV carrier without detectable HBV DNA is not excluded.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

spartalizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: November 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2022
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

KR (1)