Recruiting

Testing Less Frequent Chemotherapy Plus Immunotherapy for Advanced Lung and Head & Neck Cancers

Plain-English translation of NCT05358548 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated August 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new approach to treating advanced lung and head & neck cancers using (an immunotherapy) combined with chemotherapy on an alternating schedule. Instead of receiving chemotherapy every three weeks, participants will receive it every six weeks, with immunotherapy alone given in between cycles. The goal is to control cancer effectively while reducing the side effects and burden of frequent chemotherapy.

Current standard treatment for these cancers requires chemotherapy every three weeks, which can cause significant side effects and reduce quality of life. This trial exists to see whether spacing out chemotherapy less frequently—while still using the medication regularly—can work just as well while helping patients feel better and experience fewer complications.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced lung cancer (stage IV or certain stage III cases not eligible for surgery and radiation) or advanced head & neck cancer
you have not received chemotherapy or immunotherapy for advanced metastatic cancer before (though prior treatment for early-stage disease may be allowed if enough time has passed)
you are at least 18 years old and in overall fair to good health (ECOG performance status 0–2)
you have measurable disease on imaging scans or other evidence of cancer that was assessed within 4 weeks before enrolling

You likely don't qualify if…

you have already received chemotherapy or checkpoint inhibitor immunotherapy for advanced metastatic cancer
you have small cell lung cancer or certain genetic mutations (like EGFR, ALK, ROS1, or BRAF) that have targeted oral medications available
you have pre-existing severe nerve damage (grade 2 or higher peripheral neuropathy) if you would be receiving paclitaxel-based chemotherapy
you have a known allergy or severe sensitivity to carboplatin, paclitaxel, or other components of the study drugs

What participation looks like

Participants will receive treatment in cycles over several months to two years. During the initial phase, they will alternate between combination cycles (chemotherapy plus immunotherapy given together every six weeks) and immunotherapy-alone cycles given in between. Depending on cancer type and response, this may continue for four to six cycles before moving to a maintenance phase. Participants will have regular clinic visits for treatment infusions, blood work, and imaging scans to monitor how well the cancer is responding and to track any side effects.

AI-generated summary from trial data · Aug 11, 2026 · Not medical advice

Trial locations(11 sites)

United States

Trinitas Hospital and Comprehensive Cancer Center, Elizabeth, New Jersey

Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey

RWJBarnabas Health - Jersey City, Jersey City, New Jersey

RWJBarnabas Health - Monmouth Medical Center Southern Campus, Lakewood, New Jersey

RWJBarnabas Health - Saint Barnabas Medical Center, Livingston, New Jersey