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Checkpoint Inhibitor

Radiotherapy + Immunotherapy/PARP Inhibitor for Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By Alberto A Chiappori, 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

Participants must have small cell lung cancer, documented by histology or cytology from brushing, washing, fine needle aspiration or core biopsy from a defined lesion, but not from sputum cytology alone. No mixed histologies allowed

Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1

Must not have

Participants who have received any previous treatment with a Poly ADP Ribose Polymerase (PARP) inhibitor, including olaparib

History of allergy or hypersensitivity to any of the study drugs or study drug components

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding immunotherapy or a PARP inhibitor to thoracic radiation therapy is safe and effective in people with ES-SCLC who have responded to first-line platinum-based chemotherapy.

Who is the study for?

This trial is for adults with Small Cell Lung Cancer who've had a positive response to first-line platinum-based chemotherapy. They must be willing to use effective contraception, have no severe allergies to the study drugs, and not have received certain prior treatments that could affect results. Participants should be in good enough health with proper organ function and an expected lifespan of at least 16 weeks.

What is being tested?

The trial tests thoracic radiation followed by durvalumab alone or combined with tremelimumab or olaparib in patients who responded well to initial chemo. It's randomized, meaning participants are put into groups by chance, and it compares the safety and effectiveness of these treatment combinations.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, fatigue, digestive issues like nausea or diarrhea, blood cell count changes which can increase infection risk, liver or kidney function problems due to medication toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer diagnosis was confirmed through a biopsy, not just a sputum test.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I weigh more than 30 kg.

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My small cell lung cancer was diagnosed at an extensive stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been treated with PARP inhibitors like olaparib.

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I am not allergic to any of the drugs or their components used in this study.

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I have not had radiation therapy to the chest area before.

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I cannot have radiotherapy due to a genetic condition.

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I have cancer cells in the fluid around my brain and spinal cord.

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I have or had lung inflammation treated with steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Unacceptable Serious Adverse Events (SAEs)

Phase IB: Progression Free Survival

Secondary study objectives

Median Progression Free Survival

Overall Survival

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

Enteritis

Hypoacusis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Thoracic Radiotherapy plus Durvalumab and OlaparibExperimental Treatment3 Interventions

Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks and 300 mg orally of Olaparib twice a day

Group II: Thoracic Radiotherapy plus Durvalumab and 75mg TremelimumabExperimental Treatment3 Interventions

Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 4 doses and 75mg intravenously of Tremelimumab every 4 weeks for up to 4 doses

Group III: Thoracic Radiotherapy plus Durvalumab and 300mg TremelimumabExperimental Treatment3 Interventions

Group IV: Thoracic Radiotherapy plus DurvalumabActive Control1 Intervention

This Arm is a standard of care Arm. Patients will receive thoracic radiotherapy (30 Gray units total, 3 Gray units X 10 fractions), then in 2-3 weeks begin 1500 mg intravenously of Durvalumab every 4 weeks for up to 13 doses

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thoracic Radiotherapy

2003

Completed Phase 2

~110

Tremelimumab

2017

Completed Phase 2

~3070