Trial Outcomes & Findings for 18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma (NCT NCT03584334)

Last Updated: 2026-09-04

Results Overview

ROC curve of the FDG retention index, defined on the dual-point PET acquisition, will be analysed to distinguish lesions in true progressions and lesions in inflammatory pseudo-progressions. The Area Under the Curve (AUC) of the Receiver Operating Characteristic (ROC) curves (Sensitivity vs. Specificity) will be evaluated to assess the predictive performance of the marker. The AUC will be calculated and analyzed across three distinct delta-SUV (ΔSUV) thresholds: a decrease of 30 (-30), an increase of 30 (30), and no change (= 0).

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

12 months

Results posted on

2026-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	18FDG PET Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Overall Study STARTED	100
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18FDG PET n=95 Participants Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Age, Customized Age range · 40-49 years	7 Participants n=95 Participants
Age, Customized Age range · 50-59 years	18 Participants n=95 Participants
Age, Customized Age range · 60-69 years	35 Participants n=95 Participants
Age, Customized Age range · 70-79 years	26 Participants n=95 Participants
Age, Customized Age range · > 80 years	9 Participants n=95 Participants
Sex: Female, Male Female	42 Participants n=95 Participants
Sex: Female, Male Male	53 Participants n=95 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	18FDG PET n=95 Participants Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Threshold of the 18FDG Retention Index (Dual-point Acquisition), From the First Metabolic Progression Observed in 18FDG PET, to Distinguish a True Tumor Progression From a Pseudo-progression of Inflammatory Origin (Leukocyte Infiltrate) AUC of ROC curve (Sensitivity/Specificity) at ΔSUV: -30	0.47 Probability Interval 0.32 to 0.6
Threshold of the 18FDG Retention Index (Dual-point Acquisition), From the First Metabolic Progression Observed in 18FDG PET, to Distinguish a True Tumor Progression From a Pseudo-progression of Inflammatory Origin (Leukocyte Infiltrate) AUC of ROC curve (Sensitivity/Specificity) at ΔSUV: 30	0.49 Probability Interval 0.37 to 0.6
Threshold of the 18FDG Retention Index (Dual-point Acquisition), From the First Metabolic Progression Observed in 18FDG PET, to Distinguish a True Tumor Progression From a Pseudo-progression of Inflammatory Origin (Leukocyte Infiltrate) AUC of ROC curve (Sensitivity/Specificity) at ΔSUV: 0	0.66 Probability Interval 0.39 to 0.9

Adverse Events

18FDG PET

Serious events: 40 serious events

Other events: 86 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	18FDG PET n=95 participants at risk Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Vascular disorders Ischaemia	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Vascular disorders Peripheral arterial occlusive disease	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Vascular disorders Pulmonary embolism	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Vascular disorders Superior vena cava syndrome	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
General disorders Hyperthermia	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.1% 2/95 • from enrollment until end of follow-up, up to 1 years
Blood and lymphatic system disorders Bone marrow failure	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Cardiac disorders Atrial fibrillation	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Cardiac disorders Cardiac failure	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Gastrointestinal disorders Colitis	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
General disorders Disease complication	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
General disorders Disease progression	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
General disorders Face oedema	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
General disorders General physical health deterioration	12.6% 12/95 • from enrollment until end of follow-up, up to 1 years
General disorders Malaise	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
General disorders Pain	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
General disorders Pyrexia	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Immune system disorders Interstitial lung disease	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Infections and infestations Device related infection	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Infections and infestations Infection	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Infections and infestations Pneumonia	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Infections and infestations Subcutabneous abscess	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	2.1% 2/95 • from enrollment until end of follow-up, up to 1 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Nervous system disorders Epilepsy	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Nervous system disorders Hyperaesthesia	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Nervous system disorders Neurological symptom	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Nervous system disorders Status epilepticus	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 2/95 • from enrollment until end of follow-up, up to 1 years
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years
Vascular disorders Cerebrovascular accident	1.1% 1/95 • from enrollment until end of follow-up, up to 1 years

Other adverse events

Other adverse events
Measure	18FDG PET n=95 participants at risk Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Gastrointestinal disorders GASTROINTESTINAL AND ABDOMINAL PAINS (EXCL ORAL AND THROAT)	11.6% 11/95 • from enrollment until end of follow-up, up to 1 years
Gastrointestinal disorders GASTROINTESTINAL ATONIC AND HYPOMOTILITY DISORDERS NEC	11.6% 11/95 • from enrollment until end of follow-up, up to 1 years
Gastrointestinal disorders STOMATITIS AND ULCERATION	5.3% 5/95 • from enrollment until end of follow-up, up to 1 years
Gastrointestinal disorders GASTROINTESTINAL SIGNS AND SYMPTOMS NEC	5.3% 5/95 • from enrollment until end of follow-up, up to 1 years
General disorders ASTHENIC CONDITIONS	43.2% 41/95 • from enrollment until end of follow-up, up to 1 years
General disorders GENERAL SIGNS AND SYMPTOMS NEC	13.7% 13/95 • from enrollment until end of follow-up, up to 1 years
General disorders PAIN AND DISCOMFORT NEC	9.5% 9/95 • from enrollment until end of follow-up, up to 1 years
General disorders BODY TEMPERATURE ALTERED	5.3% 5/95 • from enrollment until end of follow-up, up to 1 years
General disorders FEBRILE DISORDERS	5.3% 5/95 • from enrollment until end of follow-up, up to 1 years
Investigations HEPATOBILIARY FUNCTION DIAGNOSTIC PROCEDURES	6.3% 6/95 • from enrollment until end of follow-up, up to 1 years
Metabolism and nutrition disorders APPETITE DISORDERS	6.3% 6/95 • from enrollment until end of follow-up, up to 1 years
Blood and lymphatic system disorders ANAEMIAS NEC	7.4% 7/95 • from enrollment until end of follow-up, up to 1 years
Endocrine disorders THYROID HYPERFUNCTION DISORDERS	7.4% 7/95 • from enrollment until end of follow-up, up to 1 years
Gastrointestinal disorders NAUSEA AND VOMITING SYMPTOMS	21.1% 20/95 • from enrollment until end of follow-up, up to 1 years
Gastrointestinal disorders DIARRHOEA (EXCL INFECTIVE)	15.8% 15/95 • from enrollment until end of follow-up, up to 1 years
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE PAIN AND DISCOMFORT	7.4% 7/95 • from enrollment until end of follow-up, up to 1 years
Nervous system disorders HEADACHES NEC	6.3% 6/95 • from enrollment until end of follow-up, up to 1 years
Nervous system disorders PERIPHERAL NEUROPATHIES NEC	6.3% 6/95 • from enrollment until end of follow-up, up to 1 years
Respiratory, thoracic and mediastinal disorders BREATHING ABNORMALITIES	31.6% 30/95 • from enrollment until end of follow-up, up to 1 years
Respiratory, thoracic and mediastinal disorders COUGHING AND ASSOCIATED SYMPTOMS	14.7% 14/95 • from enrollment until end of follow-up, up to 1 years
Skin and subcutaneous tissue disorders PRURITUS NEC	13.7% 13/95 • from enrollment until end of follow-up, up to 1 years
Skin and subcutaneous tissue disorders RASHES, ERUPTIONS AND EXANTHEMS NEC	7.4% 7/95 • from enrollment until end of follow-up, up to 1 years
Skin and subcutaneous tissue disorders DERMAL AND EPIDERMAL CONDITIONS NEC	6.3% 6/95 • from enrollment until end of follow-up, up to 1 years

Additional Information

Director of Clinical Trials

Centre Antoine Lacassagne

Phone: +334 92 03 10 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60