What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer, such as the combination of Durvalumab (a PD-L1 inhibitor), Platinum-based agents (cisplatin or carboplatin), and Etoposide, are associated with several side effects. Durvalumab can cause immune-related adverse events, including skin reactions, endocrine disorders, and pneumonitis. Platinum-based agents often lead to nephrotoxicity, neurotoxicity, and myelosuppression, while Etoposide is known for causing myelosuppression, alopecia, and gastrointestinal disturbances. These treatments can also result in fatigue, nausea, and increased risk of infections due to immunosuppression.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that are similar to the combination of Durvalumab with Platinum and Etoposide. Atezolizumab, another PD-L1 inhibitor, has been approved in combination with carboplatin and etoposide for the first-line treatment of extensive-stage SCLC. This approval was based on improved overall survival and progression-free survival compared to chemotherapy alone. Similarly, Durvalumab in combination with platinum-etoposide has shown improved survival outcomes and is used as a front-line treatment for extensive-stage SCLC.

What other types of research exist?

Promising alternatives to Durvalumab with Platinum and Etoposide for SCLC patients include: 1) Atezolizumab combined with chemotherapy, which has shown efficacy in NSCLC and may be applicable to SCLC. 2) Nivolumab plus Ipilimumab, which is being explored for various cancers and may offer benefits in SCLC. 3) Novel agents like Lurbinectedin, a transcription inhibitor, which has shown promise in relapsed SCLC. Patients should discuss these options with their oncologist to determine the best course of action based on the latest research and individual health status.

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Alkylating agents

Durvalumab + Chemotherapy for Small Cell Lung Cancer (LUMINANCE Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

No prior exposure to immune-mediated therapy including, but not limited to, other anti- CTLA-4, anti-Programmed cell death-1 (PD-1), anti- Programmed cell death ligand-1 (PD-L1), and anti-PD-L2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines

Participants must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide

Must not have

Received prior systemic therapy for ES-SCLC

Active or prior documented autoimmune or inflammatory disorders, systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study treatment to death, up to 2.5 years.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a combination of durvalumab and chemotherapy drugs (cisplatin or carboplatin, and etoposide) in patients with extensive-stage small-cell lung cancer. Durvalumab helps the immune system fight cancer, while the chemotherapy drugs kill cancer cells. The goal is to see if this combination is safe and can be tolerated by patients. Durvalumab has been shown to improve overall survival when combined with chemotherapy in extensive-stage small-cell lung cancer (SCLC).

Who is the study for?

This trial is for adults with extensive-stage small cell lung cancer who haven't had treatment before. They should be in good physical condition, have proper organ function, and weigh over 30 kg. Women must not be pregnant and participants must agree to use birth control. People can't join if they've had certain vaccines recently, previous cancer treatments for SCLC, or are on immunosuppressants.

What is being tested?

The study tests the safety of Durvalumab combined with platinum (either Cisplatin or Carboplatin) plus Etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer. It aims to see how well patients tolerate this combination therapy.

What are the potential side effects?

Possible side effects include immune-related reactions that could affect organs, infusion-related symptoms like fever or chills, fatigue, nausea or vomiting from chemotherapy drugs, blood count changes increasing infection risk and potential allergic reactions to any of the drugs used.

Eligibility Criteria

Inclusion Criteria

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

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I have not been treated with immune therapy drugs before.

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I am eligible for a first-time chemotherapy that includes platinum for my small cell lung cancer.

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My small cell lung cancer is confirmed by tests and is at an advanced stage.

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I am post-menopausal or not currently pregnant.

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My body weight is over 30 kg.

Exclusion Criteria

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

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I have had treatment for small cell lung cancer that has spread.

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I have or had lupus, sarcoidosis, or wegener syndrome.

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I don't have lasting side effects from cancer treatment worse than Grade 2.

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I do not have active infections like TB, hepatitis B, C, or HIV.

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I do not have any serious ongoing illnesses that could affect my participation in the study.

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I have not had major surgery in the last 28 days.

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I haven't taken immunosuppressive drugs in the last 14 days.

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I have previously received immunotherapy treatments.

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I cannot receive platinum-etoposide chemotherapy due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study treatment to death, up to 2.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study treatment to death, up to 2.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study treatment to death, up to 2.5 years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Incidence of Grade 3 or Higher Adverse Events (AEs)

Number of Participants With Incidence of Immune Mediated Adverse Events (imAEs)

Secondary study objectives

Duration of Response (DoR)

Number of Participants With Adverse Events and Serious Adverse Events

Number of Participants With Adverse Events of Special Interests

+6 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Durvalumab - (cisplatin or carboplatin) - EtoposideExperimental Treatment4 Interventions

Participants will receive durvalumab dose A administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w). Thereafter, durvalumab monotherapy will be continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria are met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Etoposide

2010

Completed Phase 3

~2960

Durvalumab

2017

Completed Phase 2

~3750

Cisplatin

2013

Completed Phase 3

~3120

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The combination of Durvalumab, a PD-L1 inhibitor, with platinum-based chemotherapy and etoposide targets Small Cell Lung Cancer (SCLC) through multiple mechanisms. Durvalumab enhances the immune system's ability to attack cancer cells by blocking the PD-L1/PD-1 interaction. Platinum agents like cisplatin or carboplatin cause DNA damage, inhibiting replication and transcription, while etoposide prevents DNA unwinding, leading to cell death. These treatments are vital for SCLC patients as they address the cancer's rapid and aggressive nature, improving survival and disease progression outcomes.

Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined With Chemotherapy in First-line Treatment of Small Cell Lung Cancer.