Clinical Trials Register

Summary
EudraCT Number:	2010-022950-17
Sponsor's Protocol Code Number:	IMGN0007
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-08-01
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2010-022950-17

A.3

Full title of the trial

A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine (IMGN901) in Combination with Carboplatin/Etoposide in Patients with Advanced Solid Tumors including Extensive Stage Small Cell Lung Cancer

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

An early study to test IMGN901 with carboplatin and etoposide for treating adult patients with certain types of cancer including small cell lung cancer

A.3.2

Name or abbreviated title of the trial where available

N/A

A.4.1

Sponsor's protocol code number

IMGN0007

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01237678

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ImmunoGen, Inc
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	ImmunoGen Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ImmunoGen Inc
B.5.2	Functional name of contact point	Clinical Operations Manager
B.5.3	Address:
B.5.3.1	Street Address	830 Winter Street
B.5.3.2	Town/ city	Waltham
B.5.3.3	Post code	MA 02451
B.5.3.4	Country	United States
B.5.4	Telephone number	1781895 0600
B.5.5	Fax number	1781895 0612
B.5.6	E-mail	clinicalops@immunogen.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	Yes
D.2.5.1	Orphan drug designation number	EU/3/10/792
D.3 Description of the IMP
D.3.1	Product name	Lorvotuzumab mertasine
D.3.2	Product code	IMGN901
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Lorvotuzumab mertansine
D.3.9.2	Current sponsor code	IMGN901
D.3.9.3	Other descriptive name	Maytansinoid DM1-Conjugated Humanized Monoclonal Antibody
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Phase 2: small cell lung cancer (extensive-stage disease)

E.1.1.1

Medical condition in easily understood language

Treatment of certain types of cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10049280
E.1.2	Term	Solid tumour
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10041058
E.1.2	Term	Small cell carcinoma of the lung
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy followed by
IMGN901 alone as first-line treatment for patients with extensive stage small cell lung cancer (SCLC-ED).

E.2.2

Secondary objectives of the trial

The secondary objectives are to determine the safety and tolerability of IMGN901 in combination with carboplatin/etoposide
chemotherapy followed by IMGN901 alone versus carboplatin/etoposide chemotherapy and to assess the immunogenicity of IMGN901 in combination with carboplatin.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patients ≥18 years old at the time of signing Informed Consent
2. Diagnosis
• Patients with histologically or cytologically confirmed SCLC and extensive disease as defined by the Veterans Administration Lung Cancer Group
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
4. Prior therapy
• No prior systemic chemotherapy for the treatment of SCLC
• Previous radiotherapy, including cranial irradiation, is allowed if < 30% of marrow-bearing bones were irradiated and if radiotherapy was completed at least 7 days prior to enrollment and the patient has recovered or stabilized from all adverse effects of prior radiotherapy
5. Major surgery (this does not include placement of vascular access device or tumor biopsies) must be completed 4 weeks prior to Day 1
6. Patients must have at least one measurable lesion per RECIST 1.1 guidelines for solid tumors.
7. Patients must have the following laboratory values:
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L (1500/mm3)
• Platelets ≥100.0 x 109/L (100,000/mm3)
• Hemoglobin (Hgb) ≥9 g/dL
• Serum total bilirubin ≤1.5 x ULN (upper limit of normal)
• AST (SGOT) and ALT (SGPT) ≤2.5 x ULN, except for patients with tumor involvement of the liver who must have AST and ALT ≤5 x ULN
• Serum creatinine ≤1.5 x ULN or 24-hour creatinine clearance ≥60 mL/min
• Amylase and lipase must be ≤1.5 x ULN
8. Patients must be willing and able to adhere to the study visit schedule and other protocol requirements
9. Patients or a legally authorized representative must understand and voluntarily sign an Informed Consent
10. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use 2 contraceptive methods (e.g., oral, parenteral, or implantable hormonal contraceptive; tubal ligation; intra-uterine device;
barrier contraceptive with spermicide; partner's latex condom or vasectomy). WCBP must agree to follow these requirements for at least 4 weeks after the last dose of study drug
11. WCBP must have a negative pregnancy test prior to the first dose of study treatment
12. Male patients must agree to use a latex condom even if he has had a successful vasectomy and continue to follow these requirements for at least 4 weeks following the last dose of study drug
13. Predicted survival of 3 months or more

E.4

Principal exclusion criteria

1. Concurrently receiving other anti-neoplastic treatment (e.g. chemotherapy, investigational therapy or immunotherapy including steroid therapy)
2. Grade ≥2 neurotoxicity
3. Any serious medical condition including laboratory abnormalities, or psychiatric disorder that in the opinion of the Investigator places a patient at unacceptable risk if he/she were to participate in the study
4. Clinically relevant active infection including known active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, varicella-zoster virus (shingles) or cytomegalovirus infection or any other known concurrent infectious disease which, in the judgment of the Investigator, would make a patient inappropriate for enrollment into this study
5. Significant cardiac disease such as recent myocardial infarction (≤6 months prior to Day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg ), uncontrolled cardiac arrhythmias, severe aortic stenosis, or ≥ grade 3 cardiac toxicity following prior chemotherapy
6. History of neurologic disease such as multiple sclerosis or other demyelinating disease; paraneoplastic neurologic syndrome such as Eaton-Lambert syndrome, encephalomyelitis or sensory neuropathy;
central nervous system (CNS) injury with residual neurological deficit; or has a history of hemorrhagic or ischemic stroke within the last 6 months
7. Patients with CNS metastases excluded unless previously treated with surgery or radiation and on stable, decreasing or no steroids. Patients with asymptomatic CNS metastases are eligible unless requiring steroids, anticonvulsants or other treatments to manage their CNS disease.
8. Patients with uncontrolled carcinoid syndrome (flushing, uncontrolled diarrhea, labile blood pressure)
9. Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids
10. Patients with previous history of hypersensitivity or anaphylactic reaction to IMGN901 or any of its excipients
11. Patients with previous history of hypersensitivity to etoposide or any component of its formulation
12. Patients with previous history of allergic reaction to platinum-containing compounds
13. Prior active malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer
14. Patients with a history of chronic pancreatitis or metastatic disease involving the pancreas that has been associated with an increased amylase and/or lipase
15. WCBP who are pregnant or lactating

E.5 End points

E.5.1

Primary end point(s)

Progression free survival (PFS)

E.5.1.1

Timepoint(s) of evaluation of this end point

Phase 2: 2 years after enrollment of last patient

E.5.2

Secondary end point(s)

1. Overall survival
2. PFS
3. TTP
4. ORR
5. Toxicity and tolerability
6. OS
7. PK parameters (for patients enrolled prior to Amendment 4)
8. Presence of HAHA and HADA in arm 1
9. Measurement of cytokines

E.5.2.1

Timepoint(s) of evaluation of this end point

1. 2 years after enrollment of last patient
2. 6 months
3. At scheduled visits
4. At scheduled visits
5. At scheduled visits
6. 12 months
7. Days 1, 2, 3, 8, 9 cycle 1, Days 1, 2, 3 cycle 4
8. Day 1 cycles 1, 4, 10, 15
9. Pre-dose day 1 & 8 of cycle 1 of Phase 2

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Spain

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

2 years after the enrollment of the last patient.
This is to allow sufficient time for follow-up on survival

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

160

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard of care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-09-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-05-12

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