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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00686959




Registration number
NCT00686959
Ethics application status
Date submitted
28/05/2008
Date registered
30/05/2008
Date last updated
28/06/2016

Titles & IDs
Public title
Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
Scientific title
Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology
Secondary ID [1] 0 0
H3E-MC-JMIG
Secondary ID [2] 0 0
11514
Universal Trial Number (UTN)
Trial acronym
PROCLAIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Etoposide
Treatment: Drugs - Vinorelbine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Other - Thoracic Radiation Therapy (TRT)

Experimental: Arm A: Pemetrexed + Cisplatin and TRT - Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles
Concurrent Phase:
Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles.
Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions.
Consolidation Phase:
Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles

Active Comparator: Arm B: Etoposide + Cisplatin and TRT - Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles
Concurrent Phase:
Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36
Consolidation Phase options:
Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22


Treatment: Drugs: Pemetrexed
infusion over 10 minutes

Treatment: Drugs: Cisplatin
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines

Treatment: Drugs: Etoposide
administered per local practice guidelines over a minimum of 30 minutes

Treatment: Drugs: Vinorelbine
administered over 6-10 minutes infusion per local practice guidelines

Treatment: Drugs: Paclitaxel
administered as a 3-hour infusion

Treatment: Drugs: Carboplatin
administered per local practice guidelines over 30 minutes

Treatment: Other: Thoracic Radiation Therapy (TRT)


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.
Timepoint [1] 0 0
Baseline to Date of Death from Any Cause (Up to 71.4 Months)
Secondary outcome [1] 0 0
Progression-free Survival (PFS) - Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.
Timepoint [1] 0 0
Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
Secondary outcome [2] 0 0
Objective Response Rate (Complete Response [CR] + Partial Response [PR]) - Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Timepoint [2] 0 0
Baseline to Measured Progressive Disease (Up to 7 Months)
Secondary outcome [3] 0 0
Survival Rates at 1, 2, and 3 Years - The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.
Timepoint [3] 0 0
Baseline to Date of Death from Any Cause (Up to 71.4 Months)
Secondary outcome [4] 0 0
First Site of Disease Failure in Terms of Relapse - The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.
Timepoint [4] 0 0
Baseline to Relapse (Up to 66.6 Months)
Secondary outcome [5] 0 0
Percentage of Participants With a Post Baseline Swallowing Diary Score >=4 - Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.
Timepoint [5] 0 0
Baseline through 30 Days Post Study

Eligibility
Key inclusion criteria
- Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type

- Participants must have measureable tumor lesions according to the Response Evaluation
Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on
computerized tomography (CT) scan

- Participants must be physically mobile, take care of themselves and must be up and
about and able to perform light activities, such as light housework or office work

- Participants must be 18 years of age or older

- Participants must have lost no more than 10% of their body weight in the previous 3
months

- Women must be sterile, postmenopausal, or on contraception, and men must be sterile or
on contraception

- Participants' test results assessing the function of their blood forming tissue,
kidneys, liver, and lungs must be satisfactory

- Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be
entered into this study. However, participants with cervical nodes are not permitted.
The upper border of supraclavicular nodes must not extend above the upper border of
the lateral end of the clavicle, extended medially.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants cannot have other on-going (uncontrolled) illnesses, including active
infections, recent heart problems, or psychiatric illnesses

- Participants who are unable to take vitamins (including injections of vitamin B12) or
oral cortisone medication

- Participants who have had a heart attack (myocardial infarction) or other cardiac
issues within 6 months of the trial

- Participants who have received other investigational drugs within the last 30 days

- Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily
basis or non-steroidal anti-inflammatory agents

- Participants who have diseases considered for surgical treatment as part of their care
plan, such as Pancoast or superior sulcus tumors

- Participants who had prior thoracic radiation. However, other prior radiotherapy is
allowed. Participants must have recovered from the toxic effects of the treatment
prior to study enrollment. Participants may not have received whole pelvis radiation
or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been
completed at least 30 days prior to study treatment.

- Participants who have a radiation treatment plan that would expose more than 35% of
the volume of their lung to 20 gray (Gy) or more of radiation

- Participants who have concurrent cancer from another primary site requiring treatment
of any kind within the past 5 years. Exemptions to this will be permitted on a
case-by-case basis after prior approval by the Sponsor physician or designate if the
investigator believes the participant's risk of recurrence and death is very low.
Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is
allowed. Participants with recurrence of a previously resected lung cancer or who have
a second primary lung cancer are ineligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Wollongong
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Launceston
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Frankston
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
7250 - Launceston
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment outside Australia
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the overall survival of participants with locally-advanced, Stage III
Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.
Trial website
https://clinicaltrials.gov/show/NCT00686959
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications