NCT05358548 · Rutgers, The State University of New Jersey
ATATcH Alternating Treatment Plans for Advanced Cancer
What this study is about
The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.
View original scientific description
The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.
Interventions
DRUG
Paclitaxel
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
DRUG
Pemetrexed
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
DRUG
5Fluorouracil
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
DRUG
Carboplatin
Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
DRUG
Pembrolizumab
It is a type of immunotherapy and works by helping your immune system to kill cancer cells
Primary outcome measures
Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
Time frame: up to 30 weeks
The primary endpoint of this three-arm, parallel phase II study is the percentage of patients in each of the study arms receiving 1, 2, 3 and 4 (up to 6 cycles for head and neck cancer) induction combination chemoimmunotherapy (termed "A") cycles (reflecting timepoints of 0, six weeks, twelve weeks, and eighteen weeks on study, respectively \[up to 30 weeks for patients with head and neck cancer\]).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Lung Cancer (Arms 1 and 2)
- Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition). Patients with Stage IIIB and IIIC disease are eligible if they are not candidates for combined chemotherapy and radiation; such cases should be discussed in a multidisciplinary tumor board.
- Eligible NSCLC tissue histologies will include squamous cell carcinoma (enrolled and treated in Arm 1), and nonsquamous histologies (e.g. adenocarcinoma, large cell carincoma, etc.; enrolled and treated in Arm 2). Patients with mixed squamous, e.g., adenosquamous, histology will be enrolled and treated on Study Arm 1. Patients with any evidence of Small Cell Carcinoma will be excluded from study participation.
- Patients may have ANY PD-L1 expression Tumor Proportion Score (TPS) status. Tissue testing for PD-L1 is strongly recommended. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patient may stil
Where
- Elizabeth, New Jersey
- Hamilton, New Jersey
- Jersey City, New Jersey
- Lakewood, New Jersey
- Livingston, New Jersey
- Long Branch, New Jersey
- New Brunswick, New Jersey
- Newark, New Jersey
- Somerville, New Jersey
- Toms River, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations