A study investigating the use of IO102 in combination with pembrolizumab, with or without chemotherapy, for patients with metastatic non-small cell lung cancer.
- Conditions
- Metastatic Non-Small Cell Lung CancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000139-28-ES
- Lead Sponsor
- IO Biotech Aps
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
1. Patients with histologically or cytologically confirmed metastatic NSCLC (Cohort A) or non-squamous NSCLC (Cohort B), who have not received prior systemic treatment for their metastatic disease.
a. No known EGFR mutations or ALK or ROS1 or BRAF600E genomic aberrations are permitted.
b. Solitary metastases must be biopsied to confirm the diagnosis metastasis from NSCLC
2. PD-L1 tumor expression of greater than or equal to 50% (Cohort A) or below 50% (Cohort B). PD-L1 tumour expression should be confirmed prior to randomization using the DAKO 22C3 assay, using local/central services.
3. A male participant able to father a child must agree to use contraception starting with the screening visit and through 120 days after last dose of pembrolizumab or 180 days after last dose of chemotherapy.
4. 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)
b. A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through 120 days after last dose of pembrolizumab or 180 days after last dose of chemotherapy.
5. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial in accordance with ICH-GCP and local legislation prior to admission to the trial.
6. Be ³18 years of age on day of signing informed consent.
7. Have measurable disease per RECIST 1.1 as assessed by local site investigator/radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
8. Have provided a blood sample and archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
9. Have an ECOG performance status of 0 to 1.
10. Have adequate organ function. Specimens must be collected within 10 days prior to the start of trial treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
1. A WOCBP who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. 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) and was discontinued from that treatment due to a Grade 3 or higher
immune-related AE (irAE)
3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
4. No prior radiotherapy within 2 weeks of start of trial treatment. Participants must have recovered from all radiation-related adverse events.
5. No live vaccine within 30 days prior to the first dose of trial treatment.
6. No prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial treatment.
8. No patient with a known additional malignancy that is progressing or has required active treatment within the past 2 years.
9. No patient with a known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
10. Has severe hypersensitivity (=Grade 3) to IO102, pembrolizumab, carboplatin, pemetrexed and/or any of its excipients.
11. Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment and is allowed.
12. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
13. No patient with an active infection requiring systemic therapy or known history of human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C virus infection.
14. No patient with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial.
15. Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
16. No patient who is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days (cohort A) and 180 days (cohort B) after last dose of trial treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method