Actively Recruiting
Alternating Treatment Plans for Participants With Advanced Thoracic and Head & Neck Cancers (ATATcH)
Led by Rutgers, The State University of New Jersey · Updated on 2026-04-30
150
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new schedule of alternating cycles of chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab alone) as the first treatment for patients with advanced lung or head and neck cancers. This phase II study aims to see if less frequent chemotherapy during the induction phase can effectively control the cancer while preserving quality of life. The trial also monitors safety and response rates over time. The study has three groups based on cancer type. Each group receives alternating cycles: combination chemoimmunotherapy cycles consisting of drugs like carboplatin, paclitaxel, pemetrexed, or 5-fluorouracil with pembrolizumab, followed by cycles of pembrolizumab alone. The number of cycles varies by group, with up to four or six cycles during induction. After induction, maintenance therapy with pembrolizumab alone or combined with pemetrexed continues for up to two years. Participants will have regular assessments including imaging and laboratory tests before and during treatment to measure tumor response and monitor side effects. Researchers will track how many patients complete the induction therapy cycles and evaluate overall response rates at 6 weeks. Safety is monitored throughout the study, which can last up to three years for progression and adverse event follow-up. Patients will provide informed consent and be closely monitored during the trial.
CONDITIONS
Brief Title
ATATcH Alternating Treatment Plans for Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Histologically or cytologically confirmed advanced lung cancer (stage IV NSCLC) or recurrent/metastatic head and neck squamous cell carcinoma
- ECOG performance status 0 to 2
- Measurable or non-measurable disease
- No prior systemic chemotherapy or immunotherapy for advanced or metastatic disease
- Adequate organ and marrow function based on lab tests
- Ability and willingness to sign informed consent
- Women of childbearing potential and sexually active males must agree to use effective contraception or abstain during and 120 days after treatment
You will not qualify if you...
- Known small cell lung carcinoma or mixed small cell histology
- Pre-existing peripheral neuropathy grade 2 or higher (for squamous lung cancer arm)
- Known EGFR, BRAF, MET, ALK, or ROS1 mutations treatable with targeted therapies
- Active or untreated brain metastases requiring immediate treatment
- History of autoimmune disease requiring systemic treatment within past 2 years
- Pregnant or breastfeeding women
- Current use of systemic steroids or immunosuppressive therapy within 7 days prior to treatment
- Severe infections or active tuberculosis
- Prior or concurrent malignancy that may interfere with study assessments
- Significant cardiovascular disease within 3 months prior to enrollment
- Receipt of live vaccines within 30 days prior to randomization
- Any other serious illness or organ dysfunction that may compromise safety or interfere with study results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 weeks for induction cycles; maintenance treatment up to 2 years since enrollment
Participants receive alternating treatment cycles of combination chemotherapy plus immunotherapy and immunotherapy alone during the induction phase. Maintenance treatment with chemotherapy and immunotherapy or immunotherapy alone is provided depending on cancer type and treatment response.
Up to 6 treatment cycles with visits approximately every 3 to 6 weeks
Duration - Up to 36 months
Participants are monitored for disease progression, response to treatment, and safety for up to 36 months after treatment.
Regular visits for safety and disease assessments
Trial Site Locations
Total: 11 locations
1
Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07207
Actively Recruiting
2
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Actively Recruiting
3
RWJBarnabas Health - Jersey City
Jersey City, New Jersey, United States, 07304
Actively Recruiting
4
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States, 08701
Actively Recruiting
5
RWJBarnabas Health - Saint Barnabas Medical Center
Livingston, New Jersey, United States, 10457
Actively Recruiting
6
RWJBarnabas Health - Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Actively Recruiting
7
RWJ Barnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
9
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
10
Robert Wood Johnson Somerset Hospital
Somerville, New Jersey, United States, 08876
Actively Recruiting
11
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, United States, 08755
Actively Recruiting
Research Team
M
Missak Haigentz, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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