Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Carboplatin

Pemetrexed

Pembrolizumab

Fluorouracil

Albumin-Bound Paclitaxel

Immunomodulating Agents

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

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

* 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)

* 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)

Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor

5Fluorouracil

It is a type of immunotherapy and works by helping your immune system to kill cancer cells

Missak Haigentz, MD

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.

This study is looking at the effect of alternating combination chemotherapy plus immunotherapy with immunotherapy alone during the induction phase (resulting in less frequent use of chemotherapy, once every six weeks instead of the usual every three weeks during induction) on the ability to fight your tumor. We expect that less frequent exposure to chemotherapy in this setting will control your cancer effectively while preserving your quality of life.

The primary endpoint of this three-arm, parallel phase II study is the percentage of patients receiving one, two, three and four (up to six for patients with head and neck cancer) combination chemoimmunotherapy cycles. Along with, overall response rates at six weeks and the best response rate. Additionally, to record the safety and tolerability of therapy.

There will be three groups to this study. Each group will include up to 50 patients, which means about 150 participants in total. Treatments will be given in cycles. Each induction phase cycle is made up of two parts (A \& B), and each part lasts 21 days (three weeks). If a participant has lung cancer, the goal is four cycles of induction treatment. If a participant has head \& neck cancer, the goal is six cycles. After completion of the induction phase cycles, the participant will receive additional standard maintenance phase cycles of therapy every three weeks to help control the cancer. Once the participant has stopped receiving treatment on study, they will continue to be followed up for two years. The participant will be given study treatment for as long as the tumor is responding and the participant is not experiencing severe side effects.

ATATcH Alternating Treatment Plans for Advanced Cancer

Alternating Treatment Plans for Participants With Advanced Thoracic/Head & Neck Cancers (ATATcH)

Optional on study biopsy (Exploratory Endpoint), using tumor markers

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 \[up to 30 weeks for patients with head and neck cancer\]).

via response evaluation criteria in solid tumors (RECIST 1.1)

Number of participants experiencing adverse events grade three or higher, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE, v5.0)

Spots Global Cancer Trial Database for ATATcH Alternating Treatment Plans for Advanced Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial