ILKN421H Plus Pembrolizumab in Advanced Non-Small Cell Lung Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a multicenter, open-label, phase II study to evaluate the safety, tolerability, clinical activity, and pharmacokinetics of ILKN421H in combination with pembrolizumab in participants with locally advanced or metastatic NSCLC. The study consists of 4 cohorts in participants with locally advanced or metastatic NSCLC ( squamous \[sq\] or non-squamous \[non-sq\]) without functional genomic alterations including EGFR, ALK and Ros-1, who failed systemic PD-1/L1 inhibitor treatment either alone or in combination with standard chemotherapy (post-IO) (Cohort 1 and 2), or without any prior systemic anti-cancer therapy (1L) with PDL-1 TPS ≥1% (Cohort 3 and 4). Participants will be dosed either with 1.6 mg of ILKN421H (Cohort 1 and Cohort 3) or 2.4 mg of ILKN421H (Cohort 2 and Cohort 4) in combination with 200 mg pembrolizumab. Both treatments will be administered through intravenous (i.v.) infusion every 3 weeks (Q3W) on Day 1 of each cycle with 21-day as one cycle, while ILKN421H will be dosed 4 hours after pembrolizumab. All 4 cohorts will have 3 study periods: * Screening Period: ≤ 28 days prior to first dose of study treatment; * Treatment period: 21-day cycles until unacceptable toxicity, lost to follow-up, disease progression, withdrawal of consent, death, or the sponsor closes the study, whichever occurs first; * Follow-up Period: 30-day safety follow-up and a Long-Term follow-up every 6-month for survival information.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Zaawansowany rak płuca, który nie może być operacyjnie usunięty lub nawrócił
- •Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-1)
- •Oczekiwana długość życia co najmniej 12 tygodni
- •Co najmniej jeden widoczny guz do oceny na obrazach (CT/MRI)
- •Wystarczająca funkcja narządów (wątroba, nerki, szpik kostny)
- •Dla pacjentów już leczonych: wcześniejsze leczenie inhibitorami PD-1/PD-L1
- •Dla pacjentów nieleczonych: dodatni wynik testu na białko PD-L1 w komórkach nowotworu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
Valkyrie Clinical Trials, Inc
Los Angeles, United States
Start Ccbd, Llc
Fort Worth, United States
Trial contact
Haining Huang
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.
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