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Alkylating agents

Immunotherapy + Chemotherapy for Small Cell Lung Cancer (CASPIAN 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
Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
No prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines.
Must not have
Active infection including tuberculosis, HIV, hepatitis B anc C
Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumour scans performed at baseline, week 6, week 12 then every 8 weeks relative to the date of randomization until recist 1.1-defined progression. assessed until global cohort final analysis dco (maximum of approximately 33 months).
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new combination treatment for small-cell lung cancer as compared to standard chemotherapy.

Who is the study for?
This trial is for adults with extensive-stage small cell lung cancer who have a life expectancy of at least 12 weeks, are in good physical condition (ECOG 0 or 1), and haven't had immune therapy before. They should be able to receive platinum-based chemo. Those with brain metastases must be stable without steroids or anti-convulsants for a month.
What is being tested?
The study tests if adding durvalumab alone or with tremelimumab to standard platinum-based chemotherapy (carboplatin or cisplatin plus etoposide) improves outcomes compared to just the chemo. After initial treatment, patients may continue receiving the immunotherapy drugs as maintenance.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, nausea, blood abnormalities like anemia and low white cells increasing infection risk. Specific side effects depend on each patient's reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for platinum-based chemotherapy as my first treatment.
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I have not had treatments that boost the body's natural defenses to fight cancer, except for cancer vaccines.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active infections like TB, HIV, or hepatitis.
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I have had or will have chest radiation before or after systemic therapy.
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I have a condition related to my cancer that affects other parts of my body and needs treatment.
Select...
I do not have any uncontrolled illnesses like lung disease.
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I have or had an autoimmune or inflammatory disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumour scans performed at baseline, week 6, week 12 then every 8 weeks relative to the date of randomization until recist 1.1-defined progression. assessed until global cohort final analysis dco (maximum of approximately 33 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumour scans performed at baseline, week 6, week 12 then every 8 weeks relative to the date of randomization until recist 1.1-defined progression. assessed until global cohort final analysis dco (maximum of approximately 33 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
OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP
OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP
OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP
+1 more
Secondary study objectives
APF12 in the China Cohort
APF6 in the China Cohort
Change From Baseline in Primary PRO Symptoms as Assessed by EORTC QLQ in the Global Cohort; D + T + EP Compared With EP
+25 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
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
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

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2Experimental Treatment4 Interventions
durvalumab+EP (carboplatin or cisplatin + etoposide)
Group II: Arm 1Experimental Treatment5 Interventions
durvalumab+tremelimumab+EP (carboplatin or cisplatin + etoposide)
Group III: Arm 3Active Control3 Interventions
EP (carboplatin or cisplatin + etoposide)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Tremelimumab
2017
Completed Phase 2
~3070
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
Etoposide
2010
Completed Phase 3
~2960

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,606 Total Patients Enrolled
Haiyi Jiang, M.D.Study DirectorAstraZeneca
2 Previous Clinical Trials
802 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03043872 — Phase 3
Small Cell Lung Cancer Research Study Groups: Arm 1, Arm 2, Arm 3
Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03043872 — Phase 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03043872 — Phase 3
~114 spots leftby Dec 2025
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