Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05358548

ATATcH Alternating Treatment Plans for Advanced Cancer

Led by Rutgers, The State University of New Jersey · Updated on 2026-04-30

150

Participants Needed

11

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

ATATcH Alternating Treatment Plans for Advanced Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Histologically or cytologically confirmed advanced lung cancer (stage IV NSCLC) or recurrent/metastatic squamous cell carcinoma of the head and neck
  • ECOG performance status of 0 to 2
  • Measurable or non-measurable disease as assessed by imaging within 4 weeks prior to study registration
  • No prior systemic chemotherapy or immunotherapy for advanced/metastatic disease (with some exceptions for prior non-metastatic treatment)
  • Adequate organ and marrow function as defined by laboratory tests within 14 days prior to randomization
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception
  • Ability to understand and willingness to sign informed consent
  • Patients with treated brain metastases without evidence of progression are eligible
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
  • Patients with controlled hepatitis B or cured hepatitis C infection are eligible
Not Eligible

You will not qualify if you...

  • Presence of small cell carcinoma or mixed histologies with small cell component
  • Known EGFR mutations (except exon 20 insertion), BRAF V600 mutations, MET exon 14 skipping, or ALK or ROS1 translocations treatable with oral tyrosine kinase inhibitors
  • Pre-existing peripheral neuropathy grade 2 or higher (for lung squamous cell carcinoma arm)
  • Active autoimmune disease requiring systemic treatment in the past 2 years
  • Active infections including active tuberculosis or severe infection within 4 weeks prior to randomization
  • History of solid organ or stem-cell transplantation
  • Use of systemic immunosuppressive therapy within 7 days prior to randomization (with exceptions for low-dose steroids or local therapies)
  • History of severe hypersensitivity to study drugs or similar antibodies
  • Receipt of live vaccines within 30 days prior to randomization
  • Pregnant or breastfeeding women
  • Significant cardiovascular disease within 3 months prior to randomization
  • Other serious illness or organ dysfunction that would compromise safety or study evaluation
  • Use of other investigational agents during therapy
  • Uncontrolled or symptomatic hypercalcemia
  • Untreated brain metastases or leptomeningeal disease
  • Patients unable or unwilling to comply with study procedures or contraception requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

M

Missak Haigentz, MD

CONTACT

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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