Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm, Residual

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Carboplatin

Pemetrexed

Cisplatin

Immunomodulating Agents

Nivolumab

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

All participants will have blood taken for ctDNA testing.

A cycle is 21 days. Pemetrexed (for participants with non-squamous non-small cell lung cancer), intravenously (by vein) on Day 1 of Cycles 1-4, OR gemcitabine (for all other participants) on Days 1 and 8 of Cycles 1-4.

Cisplatin\*, intravenously (by vein) on Day 1 of Cycles 1-4 Nivolumab, intravenously (by vein) on Day 1 of Cycles 1-4

\*If cisplatin is not tolerated, carboplatin may be given instead

All participants will have blood taken for ctDNA testing.

Participants will be followed as per standard of care every 3 months.

Blood will be collected for ctDNA testing

ctDNA blood test

Natasha Leighl, M.D.

Natasha Leighl

This is a study to look at whether the presence of circulating tumour DNA (ctDNA) in the blood can help to predict whether giving adjuvant treatment after surgery can decrease the chance of the cancer coming back in people with lung cancer.

For people who have early stage non-small cell lung cancer (NSCLC), the usual treatment is surgery. For many people, surgery is enough to get rid of all the cancer. However, for some people, there may be a little bit of cancer remaining. If there is some cancer left over, it may lead to the cancer regrowing. This is called relapse.

Many cancers shed little bits of their DNA (deoxyribonucleic acid, molecules that contain instructions for how cells develop and function) into the bloodstream. A blood test can be used to test for the amount of circulating tumour DNA (ctDNA). Some studies have shown that the presence of ctDNA in the blood may predict cancer recurrence.

The purpose of this research study is to see if adjuvant treatment (additional treatment given after primary treatment) can help decrease the risk of the cancer recurring in people with lung cancer who have ctDNA detected in their blood after surgery.

Using ctDNA to Determine Therapies for Lung Cancer

From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection

Bristol-Myers Squibb

University Health Network, Toronto

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Paclitaxel

Irinotecan

Pembrolizumab

Docetaxel

Leucovorin

Fluorouracil

Albumin-Bound Paclitaxel

Oxaliplatin

Folfirinox

Taxane

Tubulin Modulators

Antimitotic Agents

Topoisomerase I Inhibitors

The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If no decline in ctDNA detected after 4 cycles, treatment will be switched to a different chemotherapy backbone (e.g. irinotecan based regimen, or taxane based if not used upfront).

ctDNA will be re-evaluated after 3 cycles (if a 21 day regimen) or 4 cycles (if a 14 day regimen) of the 2nd line regimen. If ctDNA is lower than the previous measurement, then the same regimen continues for 3-4 more cycles (depending on 14 day or 21 day cycle), followed by gastrectomy. Adjuvant treatment is given based on the investigator's discretion.

ctDNA Blood Test

* Oxaliplatin 85 mg/m2 IV on Day 1
* Docetaxel 50 mg/m2 IV on Day 1
* Leucovorin 200 mg/m2 IV on Day 1
* Fluorouracil 2600 mg/m2 continuous infusion over 24 hours daily on Day 1 Every 14 Days

FLOT

* Oxaliplatin 85 mg/m2 IV on Day 1
* Leucovorin 400 mg/m2 IV on Day 1
* Fluorouracil 400 mg/m2 IV Push on Day 1
* Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days

FOLFOX

* Irinotecan 180 mg/m2 IV on Day 1
* Leucovorin 400 mg/m2 IV on Day 1
* Fluorouracil 400 mg/m2 IV Push on Day 1
* Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days

FOLFIRI

* Oxaliplatin 85 mg/m2 IV on Day 1
* Irinotecan 150 mg/m2 IV on Day 1
* Leucovorin 200 mg/m2 IV on Day 1
* Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 days

FOLFIRINOX

* Paclitaxel 200 mg/m2 IV on Day 1
* Carboplatin AUC 5 IV on day 1 Every 21 Days

OR

- Paclitaxel 80mg/m2 IV on Days 1,8,15 Every 28 Days

PACLITAXEL with or without CARBOPLATIN

* Docetaxel 35 mg/m2 IV on Days 1 and 8
* Irinotecan 50 mg/m2 IV on Days 1 and 8 Every 21 Days
* Docetaxel 75 mg/m2 IV on Day 1 Every 21 Days
* Docetaxel 150 mg/m2 IV on Day 1 Every 14 Days

DOCETAXEL and IRINOTECAN (alone or combined)

* 240 mg IV on Day 1 every 14 days, or
* 360 mg IV on Day 1 every 21 days, or
* 480 mg IV on Day 1 every 28 days

NIVOLUMAB (alone or when added to a regimen above)

* 200 mg IV on Day 1 every 21 days, or
* 400 mg IV on Day 1 every 42 days

PEMBROLIZUMAB (alone or when added to a regimen above)

Chao Family Comprehensive Cancer Center University of California, Irvine

University of California Irvine Medical

Farshid Dayyani, MD, PhD

Farshid Dayyani, MD,PhD

This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a ctDNA assay (test) result to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial

Percent of patients who will undergo attempt at curative intent resection.

Percent of patients completing gastrectomy

Percent of patients with ctDNA clearance after neoadjuvant chemotherapy and after surgery (within 6-8 weeks)

R0 resection is defined as complete tumor removal with negative surgical margins.

Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using ctDNA to Determine Therapies for Lung Cancer	NCT04966663	Non Small Cell ... Complete Surgic... Circulating Tum...	Nivolumab Pemetrexed Gemcitabine Cisplatin Carboplatin ctDNA blood tes...	18 Years -	University Health Network, Toronto
Using ctDNA to Determine Therapies for Lung Cancer	NCT04966663	Non Small Cell ... Complete Surgic... Circulating Tum...	Nivolumab Pemetrexed Gemcitabine Cisplatin Carboplatin ctDNA blood tes...	18 Years -	University Health Network, Toronto
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)	NCT05733689	Gastroesophagea...	ctDNA Blood Tes... FLOT FOLFOX FOLFIRI FOLFIRINOX PACLITAXEL with... DOCETAXEL and I... NIVOLUMAB (alon... PEMBROLIZUMAB (...	18 Years -	University of California, Irvine
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)	NCT05733689	Gastroesophagea...	ctDNA Blood Tes... FLOT FOLFOX FOLFIRI FOLFIRINOX PACLITAXEL with... DOCETAXEL and I... NIVOLUMAB (alon... PEMBROLIZUMAB (...	18 Years -	University of California, Irvine

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