ATATcH Alternating Treatment Plans for Advanced Cancer

Part of paid clinical trials in Elizabeth, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05358548
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
  • Pemetrexed — DRUG
    Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
  • 5Fluorouracil — DRUG
    Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
  • Carboplatin — DRUG
    Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
  • Pembrolizumab — DRUG
    It is a type of immunotherapy and works by helping your immune system to kill cancer cells

Study Details

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.

Key Dates

Start date
Apr 28, 2022
Status verified
Apr 2026
Primary completion
May 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Squamous Lung Cancer
    A Cycles consist of either: * Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR * nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard) B Cycles consist of Pembrolizumab alone
  • Experimental: Non-Squamous Lung Cancer
    * A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard)
  • Experimental: Head and Neck Squamous Cell Carcinoma
    * A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard)

Primary Outcome Measure

Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles [ Time Frame: up to 30 weeks ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Trinitas Hospital and Comprehensive Cancer CenterElizabethNew Jersey07207-
Cancer Institute of New Jersey at HamiltonHamiltonNew Jersey08690-
RWJBarnabas Health - Jersey CityJersey CityNew Jersey07304-
RWJBarnabas Health - Monmouth Medical Center Southern CampusLakewoodNew Jersey08701-
RWJBarnabas Health - Saint Barnabas Medical CenterLivingstonNew Jersey10457-
RWJBarnabas Health - Monmouth Medical CenterLong BranchNew Jersey07740-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903
Missak Haigentz, MD
[email protected]
732-235-2465
RWJ Barnabas Health - Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901-
RWJBarnabas Health - Newark Beth Israel Medical CenterNewarkNew Jersey07112-
Robert Wood Johnson Somerset HospitalSomervilleNew Jersey08876-
RWJBarnabas Health - Community Medical CenterToms RiverNew Jersey08755-

Find similar trials in Elizabeth, NJ

By condition
Head and neck cancerLung cancer
By specialty
OncologyENTLung oncologyLung disease
By research site
Trinitas Hospital and Comprehensive Cancer Center· Elizabeth, NJCancer Institute of New Jersey at Hamilton· Hamilton, NJRWJBarnabas Health - Jersey City· Jersey City, NJRWJBarnabas Health - Monmouth Medical Center Southern Campus· Lakewood, NJRWJBarnabas Health - Saint Barnabas Medical Center· Livingston, NJRWJBarnabas Health - Monmouth Medical Center· Long Branch, NJ

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