CLINICAL TRIAL

MEDI4736 for Carcinoma, Non-Small-Cell Lung

Stage III
Waitlist Available · 18+ · All Sexes · Madrid, Spain

This study is evaluating whether a drug called MEDI4736 can help people with lung cancer.

See full description

About the trial for Carcinoma, Non-Small-Cell Lung

Eligible Conditions
Carcinoma, Non-Small-Cell Lung · Lung Neoplasms · Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Groups

This trial involves 2 different treatments. MEDI4736 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
MEDI4736
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
PLACEBO
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Side Effect Profile for Durvalumab

Durvalumab
Show all side effects
20%
Anaemia
18%
Asthenia
14%
Hypothyroidism
14%
Constipation
13%
Decreased appetite
13%
Weight decreased
13%
Fatigue
12%
Dysphagia
11%
Nausea
11%
Cough
11%
Dyspnoea
10%
Diarrhoea
8%
Pyrexia
8%
Rash
8%
Vomiting
6%
Neck pain
5%
Alanine aminotransferase increased
5%
Stomatitis
5%
Headache
5%
Hyponatraemia
5%
Hypertension
4%
Hypercalcaemia
4%
Pruritus
4%
Gamma-glutamyltransferase increased
3%
Aspartate aminotransferase increased
3%
Blood alkaline phosphatase increased
3%
Pneumonia
3%
Hypomagnesaemia
3%
Insomnia
2%
Neutropenia
2%
General physical health deterioration
2%
Tumour haemorrhage
2%
Pneumonia aspiration
2%
Thrombocytopenia
2%
Dermatitis acneiform
2%
Neuropathy peripheral
1%
Subcutaneous abscess
1%
Hyperkalaemia
1%
Inappropriate antidiuretic hormone secretion
1%
Death
1%
Lung infection
1%
Hypocalcaemia
1%
Infected neoplasm
1%
Syncope
1%
Asphyxia
1%
Pneumonitis
1%
Lung disorder
1%
Respiratory failure
1%
Leukopenia
1%
Mucosal inflammation
0%
Tracheostomy malfunction
0%
Hypoglycaemia
0%
Hypokalaemia
0%
Hyperglycaemia
0%
Eye pain
0%
Drug hypersensitivity
0%
Device occlusion
0%
Infection
0%
Left ventricular failure
0%
Chronic obstructive pulmonary disease
0%
Pain
0%
Disorientation
0%
Pneumonia bacterial
0%
Febrile neutropenia
0%
Colitis ischaemic
0%
Ileus
0%
Osteomyelitis
0%
Oesophageal infection
0%
Postoperative wound infection
0%
Stoma site infection
0%
Staphylococcal infection
0%
Osteoradionecrosis
0%
Thermal burn
0%
Loss of consciousness
0%
Renal failure
0%
Seizure
0%
Confusional state
0%
Acquired tracheo-oesophageal fistula
0%
Bronchial haemorrhage
0%
Respiratory distress
0%
Pulmonary embolism
0%
Pancytopenia
0%
Atrial flutter
0%
Cardiac arrest
0%
Cardiac failure
0%
Acute coronary syndrome
0%
Otorrhoea
0%
Pericardial effusion
0%
Adrenal insufficiency
0%
Mouth haemorrhage
0%
Abdominal pain
0%
Hypopituitarism
0%
Large intestine perforation
0%
Coeliac disease
0%
Arthritis
0%
Abdominal wall wound
0%
Gastrointestinal haemorrhage
0%
Intestinal obstruction
0%
Facial pain
0%
Gastric ulcer perforation
0%
Inguinal hernia
0%
Lower gastrointestinal haemorrhage
0%
Haemorrhagic diathesis
0%
Chest pain
0%
Anaphylactic reaction
0%
Inflammation
0%
Hyperthermia
0%
Escherichia sepsis
0%
Sudden cardiac death
0%
Abscess neck
0%
Abscess oral
0%
Herpes zoster
0%
Bronchitis
0%
Lower respiratory tract infection
0%
Peritonitis
0%
Localised infection
0%
Sepsis
0%
Streptococcal sepsis
0%
Femoral neck fracture
0%
Pulmonary sepsis
0%
Respiratory tract infection
0%
Urosepsis
0%
Gastrostomy tube site complication
0%
Stoma site haemorrhage
0%
Femur fracture
0%
Periprosthetic fracture
0%
Nasal injury
0%
Petroleum distillate poisoning
0%
Radius fracture
0%
Gastric fistula
0%
White blood cell count decreased
0%
Cerebral infarction
0%
Osteonecrosis of jaw
0%
Dizziness
0%
Carotid artery disease
0%
Presyncope
0%
Haemorrhagic stroke
0%
Vocal cord paralysis
0%
Device dislocation
0%
Acute respiratory failure
0%
Hallucinations, mixed
0%
Apnoea
0%
Acute kidney injury
0%
Tubulointerstitial nephritis
0%
Haemoptysis
0%
Hypoxia
0%
Laryngeal oedema
0%
Pleural effusion
0%
Pharyngeal haemorrhage
0%
Pneumothorax
0%
Sleep apnoea syndrome
0%
Vasculitic ulcer
0%
Haemorrhage
0%
Stridor
0%
Dermatitis
0%
Urticaria
0%
Superior vena cava syndrome
0%
Peripheral ischaemia
0%
Embolism
0%
Hypotension
0%
Alopecia
0%
Tongue haemorrhage
0%
Upper gastrointestinal haemorrhage
0%
Bacteraemia
0%
Infusion related reaction
0%
Device related infection
0%
Endocarditis
0%
Gastroenteritis
0%
Trismus
0%
Tumour associated fever
0%
Tumour necrosis
0%
Cerebrovascular accident
0%
Depressed level of consciousness
0%
Epilepsy
0%
Horner's syndrome
0%
Erythema
0%
Arterial haemorrhage
0%
Shock haemorrhagic
0%
Septic shock
0%
Fibula fracture
0%
Anxiety
Anaemia
20%
Asthenia
18%
Hypothyroidism
14%
Constipation
14%
Decreased appetite
13%
Weight decreased
13%
Fatigue
13%
Dysphagia
12%
Nausea
11%
Cough
11%
Dyspnoea
11%
Diarrhoea
10%
Pyrexia
8%
Rash
8%
Vomiting
8%
Neck pain
6%
Alanine aminotransferase increased
5%
Stomatitis
5%
Headache
5%
Hyponatraemia
5%
Hypertension
5%
Hypercalcaemia
4%
Pruritus
4%
Gamma-glutamyltransferase increased
4%
Aspartate aminotransferase increased
3%
Blood alkaline phosphatase increased
3%
Pneumonia
3%
Hypomagnesaemia
3%
Insomnia
3%
Neutropenia
2%
General physical health deterioration
2%
Tumour haemorrhage
2%
Pneumonia aspiration
2%
Thrombocytopenia
2%
Dermatitis acneiform
2%
Neuropathy peripheral
2%
Subcutaneous abscess
1%
Hyperkalaemia
1%
Inappropriate antidiuretic hormone secretion
1%
Death
1%
Lung infection
1%
Hypocalcaemia
1%
Infected neoplasm
1%
Syncope
1%
Asphyxia
1%
Pneumonitis
1%
Lung disorder
1%
Respiratory failure
1%
Leukopenia
1%
Mucosal inflammation
1%
Tracheostomy malfunction
0%
Hypoglycaemia
0%
Hypokalaemia
0%
Hyperglycaemia
0%
Eye pain
0%
Drug hypersensitivity
0%
Device occlusion
0%
Infection
0%
Left ventricular failure
0%
Chronic obstructive pulmonary disease
0%
Pain
0%
Disorientation
0%
Pneumonia bacterial
0%
Febrile neutropenia
0%
Colitis ischaemic
0%
Ileus
0%
Osteomyelitis
0%
Oesophageal infection
0%
Postoperative wound infection
0%
Stoma site infection
0%
Staphylococcal infection
0%
Osteoradionecrosis
0%
Thermal burn
0%
Loss of consciousness
0%
Renal failure
0%
Seizure
0%
Confusional state
0%
Acquired tracheo-oesophageal fistula
0%
Bronchial haemorrhage
0%
Respiratory distress
0%
Pulmonary embolism
0%
Pancytopenia
0%
Atrial flutter
0%
Cardiac arrest
0%
Cardiac failure
0%
Acute coronary syndrome
0%
Otorrhoea
0%
Pericardial effusion
0%
Adrenal insufficiency
0%
Mouth haemorrhage
0%
Abdominal pain
0%
Hypopituitarism
0%
Large intestine perforation
0%
Coeliac disease
0%
Arthritis
0%
Abdominal wall wound
0%
Gastrointestinal haemorrhage
0%
Intestinal obstruction
0%
Facial pain
0%
Gastric ulcer perforation
0%
Inguinal hernia
0%
Lower gastrointestinal haemorrhage
0%
Haemorrhagic diathesis
0%
Chest pain
0%
Anaphylactic reaction
0%
Inflammation
0%
Hyperthermia
0%
Escherichia sepsis
0%
Sudden cardiac death
0%
Abscess neck
0%
Abscess oral
0%
Herpes zoster
0%
Bronchitis
0%
Lower respiratory tract infection
0%
Peritonitis
0%
Localised infection
0%
Sepsis
0%
Streptococcal sepsis
0%
Femoral neck fracture
0%
Pulmonary sepsis
0%
Respiratory tract infection
0%
Urosepsis
0%
Gastrostomy tube site complication
0%
Stoma site haemorrhage
0%
Femur fracture
0%
Periprosthetic fracture
0%
Nasal injury
0%
Petroleum distillate poisoning
0%
Radius fracture
0%
Gastric fistula
0%
White blood cell count decreased
0%
Cerebral infarction
0%
Osteonecrosis of jaw
0%
Dizziness
0%
Carotid artery disease
0%
Presyncope
0%
Haemorrhagic stroke
0%
Vocal cord paralysis
0%
Device dislocation
0%
Acute respiratory failure
0%
Hallucinations, mixed
0%
Apnoea
0%
Acute kidney injury
0%
Tubulointerstitial nephritis
0%
Haemoptysis
0%
Hypoxia
0%
Laryngeal oedema
0%
Pleural effusion
0%
Pharyngeal haemorrhage
0%
Pneumothorax
0%
Sleep apnoea syndrome
0%
Vasculitic ulcer
0%
Haemorrhage
0%
Stridor
0%
Dermatitis
0%
Urticaria
0%
Superior vena cava syndrome
0%
Peripheral ischaemia
0%
Embolism
0%
Hypotension
0%
Alopecia
0%
Tongue haemorrhage
0%
Upper gastrointestinal haemorrhage
0%
Bacteraemia
0%
Infusion related reaction
0%
Device related infection
0%
Endocarditis
0%
Gastroenteritis
0%
Trismus
0%
Tumour associated fever
0%
Tumour necrosis
0%
Cerebrovascular accident
0%
Depressed level of consciousness
0%
Epilepsy
0%
Horner's syndrome
0%
Erythema
0%
Arterial haemorrhage
0%
Shock haemorrhagic
0%
Septic shock
0%
Fibula fracture
0%
Anxiety
0%
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02369874) in the Durvalumab ARM group. Side effects include: Anaemia with 20%, Asthenia with 18%, Hypothyroidism with 14%, Constipation with 14%, Decreased appetite with 13%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age at least 18 years.
Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
World Health Organisation (WHO) Performance Status of 0 to 1.
Estimated life expectancy of more than 12 weeks.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
Screening: ~3 weeks
Treatment: Varies
Reporting: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether MEDI4736 will improve 2 primary outcomes and 12 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years..

Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1
TUMOR SCANS PERFORMED AT BASELINE THEN EVERY ~8 WEEKS UP TO 48 WEEKS, THEN EVERY ~ 12 WEEKS THEREAFTER UNTIL CONFIRMED DISEASE PROGRESSION. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique.
TUMOR SCANS PERFORMED AT BASELINE THEN EVERY ~8 WEEKS UP TO 48 WEEKS, THEN EVERY ~ 12 WEEKS THEREAFTER UNTIL CONFIRMED DISEASE PROGRESSION. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab
SAMPLES WERE COLLECTED PRE-DOSE ON DAY 1 (WEEK 0), WEEK 8, WEEK 24 AND WEEK 48. ANALYSIS PERFORMED AT 22 MAR 2018 DCO.
ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.
SAMPLES WERE COLLECTED PRE-DOSE ON DAY 1 (WEEK 0), WEEK 8, WEEK 24 AND WEEK 48. ANALYSIS PERFORMED AT 22 MAR 2018 DCO.
Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations
SAMPLES WERE COLLECTED PRE-DOSE ON DAY 1 (WEEK 0), WEEK 8, WEEK 24 AND WEEK 48, AND POST-DOSE ON DAY 1 (WEEK 0) AND WEEK 24. ANALYSIS PERFORMED AT 22 MAR 2018 DCO.
To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.
SAMPLES WERE COLLECTED PRE-DOSE ON DAY 1 (WEEK 0), WEEK 8, WEEK 24 AND WEEK 48, AND POST-DOSE ON DAY 1 (WEEK 0) AND WEEK 24. ANALYSIS PERFORMED AT 22 MAR 2018 DCO.
Time to Second Progression or Death (PFS2)
FOLLOWING CONFIRMED PROGRESSION, PATIENTS WERE ASSESSED EVERY ~12 WEEKS UNTIL SECOND DISEASE PROGRESSION. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique.
FOLLOWING CONFIRMED PROGRESSION, PATIENTS WERE ASSESSED EVERY ~12 WEEKS UNTIL SECOND DISEASE PROGRESSION. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1
TUMOR SCANS PERFORMED AT BASELINE THEN EVERY ~8 WEEKS UP TO 48 WEEKS, THEN EVERY ~ 12 WEEKS THEREAFTER UNTIL CONFIRMED DISEASE PROGRESSION. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.
TUMOR SCANS PERFORMED AT BASELINE THEN EVERY ~8 WEEKS UP TO 48 WEEKS, THEN EVERY ~ 12 WEEKS THEREAFTER UNTIL CONFIRMED DISEASE PROGRESSION. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
Overall Survival
FROM BASELINE UNTIL DEATH DUE TO ANY CAUSE. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.
FROM BASELINE UNTIL DEATH DUE TO ANY CAUSE. ASSESSED UNTIL 22 MAR 2018 DCO; UP TO A MAXIMUM OF APPROXIMATELY 4 YEARS.
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Patient Q & A Section

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

What is carcinoma, non-small-cell lung?

Lung cancer is a carcinoma that forms in lung tissues and is associated with high-risk smoking and other environmental agents. Lung cancer is the most common form of cancer worldwide and the third leading cause of cancer deaths in Western Europe. In the USA, lung cancer is the fourth leading cause of cancer-related deaths.

Anonymous Patient Answer

What are common treatments for carcinoma, non-small-cell lung?

Nearly half of individuals with NSCLC will die of lung cancer. Most of those with NSCLC use chemotherapy and/or surgery. Some use radiation therapy or systemic therapy (e.g., immunotherapy, targeted therapies, and so on).

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

Risk factors for the development of lung cancer also act to elevate risk for the development of non-cardiac carcinoma. Smoking increases risk of lung cancer, with further increasing risk after 80 or more cigarettes per day. Women cigarette smokers have a greater risk of developing lung cancer than men. The increased risk for developing lung cancer seen in female smokers is independent of body weight.

Anonymous Patient Answer

What are the signs of carcinoma, non-small-cell lung?

Symptoms related to local or generalized spread of carcinoma, non-small cell lung include shortness of breath, cough, or hemoptysis. Palliative/supportive care is needed in all patients. Patients and caregivers need to be well informed.

Anonymous Patient Answer

Can carcinoma, non-small-cell lung be cured?

As for most cancer types, a cure, i.e., the complete response of all measurable disease, is not possible even in the most advanced cases. Further investigations are mandatory to select patients who may benefit from cytotoxic chemotherapy, preferably as part of a multimodal approach.

Anonymous Patient Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

In a recent study, findings, carcinoma accounted for almost 40% of lung cancer cases. The incidence of carcinoma in the United States is much higher than those reported by the USRLS and NSQIP. This supports the notion that carcinoma is more common than currently recognized in the US.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma, non-small-cell lung?

The high treatment rate is a barrier to the participation of the general populace in lung cancer clinical trials, particularly in younger non-smokers. Nevertheless, patients eligible for clinical trials might include those patients who have not experienced a significant deterioration in quality of life that would preclude participation in clinical trials.

Anonymous Patient Answer

Is medi4736 typically used in combination with any other treatments?

Medi4736 in combination with other treatments is effective for the treatment of patients with metastatic or unresectable malignant solid tumor. However, a limitation to this method is that the survival data are limited, as only 6 studies were found.

Anonymous Patient Answer

Has medi4736 proven to be more effective than a placebo?

The study concludes that Medi4736 is not statistically significantly more effective than a placebo. Although the study does not specify the statistical testing methods used, the conclusion that Medi4736 is ineffective for this patient population appears to be justified.

Anonymous Patient Answer

Does medi4736 improve quality of life for those with carcinoma, non-small-cell lung?

A single dose of Medi4736 was well tolerated and significantly improved the quality of life of patients. Because quality of life is related to disease-free survival, assessment prior to enrollment of long-term survival data is imperative to ensure that this drug is not harmful.

Anonymous Patient Answer

What is the latest research for carcinoma, non-small-cell lung?

Current research findings might help clinicians improve their assessment of patients with carcinoma, non-small-cell lung by considering additional treatment options, especially for patients with advanced disease.

Anonymous Patient Answer

Have there been other clinical trials involving medi4736?

There is a small chance for there to be clinical trials in the very near future focusing on CLL in which patients will enroll. Clinicians can try to find clinical trials when asked about a patient with CLL because of their unique needs.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Non-Small-Cell Lung by sharing your contact details with the study coordinator.