Pembrolizumab with standard cytotoxic chemotherapy in treatment naive non-small cell lung cancer patients with asymptomatic brain metastases

Not Applicable

Not yet recruiting

• Conditions: Neoplasms

• Registration Number: KCT0006563
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 5 October 2021

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Male/female participants who are at least 19 years of age on the day of signing informed consent with histologically confirmed diagnosis of stage IV non-small cell lung cancer with asymptomatic brain metastases will be enrolled in this study.
2. Must have at least one intracranial target lesion. Intracranial lesion must be equal or greater than the 10mm in longest diameter.
3. Have confirmation that EGFR or ALK-directed therapy is not indicated (documentation of absence of tumor activating EGFR mutations AND absence of ALK gene rearrangements OR presence of a K-Ras mutation. However, patients with squamous histology are eligible without genomic data)
4. Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Otherwise, previously treated with radiation is not considered as measurable lesion.
5. Have not received prior systemic treatment for their advanced/metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
6. Have a life expectancy of at least 3 months
7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
8. Have adequate organ function
- Hematological: Absolute neutrophil count (ANC) = 1500/µL
Platelets = 100 000/µL
Hemoglobin = 9.0 g/dL or = 5.6 mmol/La
- Renal: Creatinine OR Measured or calculatedb creatinine clearance = 1.5 × ULN OR = 30 mL/min for participant with creatinine levels > 1.5 × institutional ULN
- Hepatic: Total bilirubin = 1.5 ×ULN OR direct bilirubin = ULN for participants with total bilirubin levels > 1.5 × ULN
AST (SGOT) and ALT (SGPT) = 2.5 × ULN (= 5 × ULN for participants with liver metastases)
- Coagulation: INR OR PT/aPTT = 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
9. Male participants:
A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
10. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
a. Not a woman of childbearing potential(WOCBP)
OR
b. A woman of childbearing potential(WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
11. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.

Exclusion Criteria

1. A woman of childbearing potential(WOCBP) who has a positive urine pregnancy test within 72 hours prior to IP administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
3. Has received prior systemic anti-cancer therapy including investigational agents prior to IP administration as a metastatic disease treatment, including tyrosine kinase inhibitor.
4. Had major surgery < 3 weeks prior to first dose
5. No measurable CNS lesion other than CNS lesion treated with stereotactic radiotherapy or surgery
6. Had received whole brain radiotherapy or stereotactic radiotherapy to CNS disease.
7. Has received prior radiotherapy within 1 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-CNS disease.
8. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
9. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
10. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
11. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid cancer or early gastric cancer or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
12. Has known active carcinomatous meningitis.
13. Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.
14. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
15. Has a history of (non-infectious) pneumonitis that currently required steroids or has current pneumonitis.
16. Has an active infection requiring systemic therapy.
17. Has a known history of Human Immunodeficiency Virus (HIV) infection.
18. Has a active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive with HBV DNA positive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. These patients can be participated with appropriate treatment and pr

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified