Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Paclitaxel

Carboplatin

Pemetrexed

Pembrolizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

* For the first two cycles, Pembrolizumab will be administered at a predetermined dose every 3 weeks.
* InVision plasma draw will take place at Cycle 1 Day 1 and Cycle 2 Day 1, with return of results to the treating oncologist prior to Cycle 3 Day 1.
* At Cycle 3, patients will be re-registered per the inclusion criteria into 3 arms;

  * PEMBROLIZUMAB Alone
  * PEMBROLIZUMAB + Doublet Chemotherapy

- Following imaging assessment at Cycle 3, participants will continue pembrolizumab alone if the following responses are observed:

* Response of Partial Response/Complete Response
* Response of Stable Disease with plasma response
* Response of Progressive Disease without worsening cancer symptoms AND plasma response

* Following imaging assessment at Cycle 3, participants will receive pembrolizumab in combination with platinum doublet chemotherapy if they have a response of stable disease without plasma response, OR no plasma response and response of progressive disease without worsening cancer systems. Platinum doublet should be histology-appropriate and will be given on-label, per treating oncologist.
* PEMBROLIZUMAB
* Chemotherapy multiple agents systemic

  * PEMETREXED
  * CARBOPLATIN
  * PACLITAXEL

predetermined dose, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.

administered per standard practice, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.

PEMETREXED

administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.

CARBOPLATIN

PACLITAXEL

Plasma draw for clinical test performed at C1D1 and C2D1; plasma draw for research testing performed at other timepoints per protocol.

InVision

Julia K Rotow, MD

This research study is studying to see if a blood test, collected at different times during the treatment of metastatic non-small lung cancer, can be used to detect early response in patients being treated with pembrolizumab and use that information to determine whether patients should continue treatment with pembrolizumab or switch treatment to pembrolizumab in combination with chemotherapy.

The names of the study drugs involved in this study are:

* Pembrolizumab
* Platinum doublet chemotherapy, which may include the following:

  * Carboplatin and pemetrexed
  * Carboplatin and paclitaxel

The name of the blood test:

- InVision (Inivata, Ltd.)

This is an open label, single institution, prospective pilot study.

The purpose of this research study is to determine if a blood test, collected at different times during treatment, can be used to detect early response in patients being treated with pembrolizumab for lung cancer and use that information to determine whether patients should continue treatment with pembrolizumab or switch treatment to pembrolizumab in combination with chemotherapy.

-The research study procedures include screening for eligibility and study treatment including evaluations approximately every 3 weeks.

The names of the study drugs involved in this study are:

* Pembrolizumab
* Platinum doublet chemotherapy, which may include the following:

  * Carboplatin and pemetrexed
  * Carboplatin and paclitaxel

The name of the blood test:

* InVision- Inivata

  * This blood test that will help study how participants respond to the study treatment. ---
  * Blood will be collected for this test at a few time points, both before and after participants receive treatment on study.
* Participants will be on the research study for up to 12 months.
* It is expected that about 40 people will take part in this research study.

Plasma-Adapted First-Line Pembro In NSCLC

Pilot Study of Serial Plasma Genotyping to Guide the Adaptive Treatment of Advanced NSCLC Receiving First-line Pembrolizumab

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Early plasma response is defined as ≥50% reduction in plasma ctDNA max AF between Cycle 1 Day 1 and Cycle 2 Day 1 for patients with high shed \[≥0.5% max AF\] at Cycle 1 Day 1, or persistent low shed \[\<0.5% max AF\] for patients with low shed at Cycle 1 Day 1.

Kaplan-Meier method will be used to estimate event-time distributions and medians for time-to-event data

Feasibility is defined as a patient's adherence to protocol therapy for 4 cycles

Spots Global Cancer Trial Database for invision

Every month we try and update this database with for invision cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for invision

Every month we try and update this database with for invision cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for invision cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.