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Checkpoint Inhibitor

Thoracic Radiotherapy for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Bradford Perez, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post treatment

Awards & highlights

Study Summary

This trial is to see if a new immunotherapy drug combo can help Stage III NSCLC patients live longer without disease progression than the current standard of care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants Without Disease Progression at 12 Months

Unacceptable Toxicity Status at the End of 8-week Safety Observation Period

Secondary outcome measures

Objective Response Rate (ORR) at 6 Months

Percentage of Participants Who Experienced 12 Month Distant Metastasis Free Survival (DMFS)

Side effects data

From 2013 Phase 2 trial • 90 Patients • NCT01000480

48%

Nausea

30%

Dysphagia

26%

Oesophagitis

24%

Constipation

20%

Asthenia

19%

Neutropenia

16%

Fatigue

16%

Cough

14%

Dyspnoea

13%

Leukopenia

12%

Vomiting

11%

Stomatitis

11%

Radiation oesophagitis

11%

Radiation skin injury

Diarrhoea

Pyrexia

Decreased appetite

Dyspepsia

Haemoglobin decreased

Anaemia

Dizziness

Dysgeusia

Conjunctivitis

Back pain

Rash

Lymphopenia

Vertigo

White blood cell count decreased

Neutrophil count decreased

Chest pain

Thrombocytopenia

Pulmonary embolism

General physical health deterioration

Dehydration

Hypoacusis

Enteritis

Gastritis erosive

Device related infection

Pneumonia

Septic shock

Hyponatraemia

Cerebrovascular accident

Paraesthesia

Syncope

Renal impairment

Urinary retention

100%

80%

60%

40%

20%

Study treatment Arm

Pemetrexed, Cisplatin, and Thoracic Radiotherapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Radiation and ChemotherapyExperimental Treatment3 Interventions

Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab.

Group II: NivolumabExperimental Treatment1 Intervention

Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ipilimumab

2016

Completed Phase 3

~5520

Thoracic Radiotherapy

2003

Completed Phase 2

~110

Nivolumab

2014

Completed Phase 3

~4750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,463 Total Patients Enrolled

Bradford Perez, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Frequently Asked Questions

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

Are there any other examinations that have evaluated the efficacy of Thoracic Radiotherapy?

"Presently, there are 918 trials underway for Thoracic Radiotherapy. 144 of these ongoing clinical studies have reached Phase 3. While the majority of investigations take place in Xiamen, Fujian; across 59988 sites globally, this treatment is being researched."

Answered by AI

How many individuals are eligible for this research program?

"This particular trial is not presently looking for participants. The research, initially published on November 20th 2018 and most recently updated September 30th 2022, has concluded its recruitment period. If you are in search of other trials accepting patients with carcinoma or non-small cell lung cancer, 1361 studies can be found; 918 concerning Thoracic Radiotherapy have likewise open enrolment."

Answered by AI

Are there any new openings for participants in this medical experiment?

"According to clinicaltrials.gov, this trial is not currently recruiting patients; the first posting date was November 20th 2018 and most recent update was September 30th 2022. Despite this particular study being closed for recruitment, there are a plethora of other medical trials that still require participants at present."

Answered by AI

What maladies are commonly addressed with Thoracic Radiotherapy?

"Thoracic Radiotherapy has been used to address issues related to anti-angiogenic therapy. This radiation treatment is also beneficial for treating various malignant neoplasms, unresectable melanomas and squamous cell carcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)

2018. "Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03663166.