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Chemotherapy

Chemotherapy + Immunotherapy for Lung Cancer

Phase 2
Recruiting
Led By Missak Haigentz, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with any evidence of Small Cell Carcinoma will be excluded from study participation
Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new way to treat lung or head and neck cancer by combining chemotherapy and immunotherapy.

Who is the study for?
This trial is for adults with advanced lung or head and neck cancers. Participants must have a certain level of physical fitness (ECOG 0-2) and measurable disease. They should not be pregnant, breastfeeding, or have severe infections, organ transplants, autoimmune diseases requiring treatment in the past 2 years, known specific cancer mutations, or pre-existing severe lung conditions.Check my eligibility
What is being tested?
The study tests alternating cycles of chemoimmunotherapy (chemo drugs like Paclitaxel combined with Pembrolizumab) and immunotherapy alone as initial treatments. It aims to see if changing treatment types can better manage advanced cancers.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, immune system complications leading to inflammation in various organs, fatigue from chemotherapy drugs like Carboplatin and Pemetrexed, digestive issues such as diarrhea from 5Fluorouracil, blood disorders due to bone marrow suppression by chemotherapeutic agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is not small cell carcinoma.
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My lung cancer is at stage IV.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
Secondary outcome measures
Overall response rates
Progression Free Survival
Safety as assessed by number of participants experiencing adverse events
Other outcome measures
Health Related Quality of Life (HRQoL) assessment (Head and Neck Cancer)
Malignant Neoplasms
Tumor immune microenvironment (TME) evaluation of biopsy tissues, via tumor markers

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Group I: Squamous Lung CancerExperimental Treatment3 Interventions
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
Group II: Non-Squamous Lung CancerExperimental Treatment3 Interventions
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)
Group III: Head and Neck Squamous Cell CarcinomaExperimental Treatment3 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed
2014
Completed Phase 3
~5250
5Fluorouracil
2020
Completed Phase 3
~900
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
426 Previous Clinical Trials
63,995 Total Patients Enrolled
Missak Haigentz, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Media Library

5Fluorouracil (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05358548 — Phase 2
Lung Cancer Research Study Groups: Squamous Lung Cancer, Non-Squamous Lung Cancer, Head and Neck Squamous Cell Carcinoma
Lung Cancer Clinical Trial 2023: 5Fluorouracil Highlights & Side Effects. Trial Name: NCT05358548 — Phase 2
5Fluorouracil (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358548 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there various locations where this research is being conducted around the state?

"Patients can enroll in this clinical trial at 11 different locations, including RWJBarnabas Health - Saint Barnabas Medical Center in Livingston, Robert Wood Johnson Somerset Hospital in Somerville and RWJBarnabas Health - Community Medical Center in Toms River."

Answered by AI

How many participants are engaged in this clinical trial?

"Affirmative. The clinicaltrials.gov database reveals that this research undertaking, initially posted on April 28th 2022, is currently accepting participants. 150 people are required to join from 11 different medical facilities."

Answered by AI

What potential harms could be associated with the administration of Pembrolizumab?

"Our internal rating at Power granted pembrolizumab a 2, taking into consideration the Phase II trial's data on safety but absence of information concerning efficacy."

Answered by AI

Are there any opportunities to enroll in this clinical study at present?

"Yes, this medical trial is still open for applicants. It was first posted on April 28th 2022 and the criteria were revised as recently as October 13th of that same year."

Answered by AI
~54 spots leftby May 2025