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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
Histologically or cytologically documented extensive disease. Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
Suitable to receive a platinum-based chemotherapy regimen as 1st line treatment.
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

CASPIAN Trial 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.Check my eligibility
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.See study design
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.

CASPIAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has spread widely, and any brain metastases are stable without needing steroids or anti-convulsants for over a month.
Select...
I am eligible for platinum-based chemotherapy as my first treatment.
Select...
I have not had treatments that boost the body's natural defenses to fight cancer, except for cancer vaccines.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have not had treatments that boost the body's natural defenses to fight cancer, except for cancer vaccines.
Select...
I am eligible for platinum-based chemotherapy as my first treatment.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

CASPIAN Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

CASPIAN 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
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,470,434 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

Frequently Asked Questions

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

Are participants being enrolled in this experiment right now?

"No, this particular research study is not currently looking for more participants. Although, according to the latest update on September 26th, 2022, it is inactive, there are 5531 other trials that are recruiting."

Answered by AI

Does this research include elderly citizens as test subjects?

"According to the inclusion criteria found on clinicaltrials.gov, people between 18-130 years old may apply for this particular trial. Out of the 5644 total clinical trials, 287 are for patients under 18 and 5357 are for patients 65 and older."

Answered by AI

Why did researchers initiate this clinical trial?

"The primary objective of this trial, as measured over a period of approximately 33 months, is overall survival. This will be assessed at an interim analysis and compared between the durvalumab + epacadostat + pembrolizumab group and the epacadostat + pembrolizumab group. Other secondary outcomes being assessed include the number of patients with an ADA response to durvalumab, time to deterioration of global health status/HRQoL, and change from baseline in primary PRO symptoms."

Answered by AI

For what sorts of conditions is Durvalumab most often prescribed?

"Hodgkin disease is one of many conditions treatable by Durvalumab. This medication can also target other issues like malignant pleural mesothelioma, advanced head and neck cancer, and advance directives."

Answered by AI

In how many different medical institutions is this clinical trial being overseen?

"There are presently 20 sites running this particular clinical trial. The locations are based in Muncie, Birmingham and Nashville along with other locations 20 other locations. It is helpful to select the clinic closest you to minimize travel demands if you enroll."

Answered by AI

Has Durvalumab received approval from the Federal Drug Administration?

"There is both existing efficacy data and multiple rounds of safety data, so Durvalumab was given a score of 3."

Answered by AI

Who does this clinical trial apply to?

"This study is looking for 987 people with carcinoma that meet the age requirements of 18-130. The most important requirements are as follows: a histological or cytological documentation of extensive disease, brain metastases that are asymptomatic or have been treated and have been stable for at least a month prior to study treatment, the ability to receive a platinum-based chemotherapy regimen, a life expectancy of at least 12 weeks, an ECOG score of 0 or 1, and no prior exposure to immune-mediated therapy with the exception of therapeutic anticancer vaccines."

Answered by AI

With what other drugs has Durvalumab been tested in previous clinical trials?

"City of Hope Comprehensive Cancer Center was the first institution to study durvalumab, back in 1997. As of now, there have been 2020 completed studies and 1588 active clinical trials. A large portion of these trials take place in Muncie, Indiana."

Answered by AI

Who else is applying?

What state do they live in?
Other
Indiana
Ohio
California
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
~123 spots leftby Mar 2025